International Journal of Tissue Repair
type: channel
description: ​​The International Journal of Tissue Repair (IJTR) is a global, open-access, peer-reviewed journal focused on cutting-edge research in wound healing and tissue repair, especially in the Cellular, Acellular, Matrix-like Products (CAMPs) space. IJTR publishes a wide range of content, including research articles, reviews, clinical trials, and guidelines. Supported by international experts, IJTR serves healthcare professionals dedicated to advancing wound care and tissue repair.
publisher: KERNEXUS MEDICAL COMMUNICATIONS LTD
language: en
publication name: International Journal of Tissue Repair
issn: 2755-841X
items: Expert guidance for a pragmatic, evidence-based framework for skin substitutes (CTPs/CAMPs) across all chronic wound types
items: Efficacy of a dehydrated porcine placental extracellular matrix for the treatment of multiple chronic wound types in a private practice model: a retrospective feasibility study
items: Evaluation of intact fish skin grafts plus standard care in the treatment of venous leg ulcers: an interim analysis of the THOR trial
items: Update: CMS Final DFU/VLU CAMP LCDs Effective January 1, 2026: Covered, Cut, Status Quo, and Emerging Collateral Statutory Constraints
items: Evaluation of single layer amniotic membrane in the management of nonhealing diabetic foot ulcers: an interim analysis of CAMPX
items: Real world evidence retrospective study to evaluate the safety and efficacy of an amniotic membrane allograft for venous leg ulcers in a post-acute care setting
items: Evaluation of lyophilized human amnion/chorion membrane (LHACM) in the management of nonhealing diabetic foot ulcers: an interim analysis of the CAMPAIGN trial
items: A prospective, multicenter, randomized, controlled trial of non-healing diabetic foot ulcers treated with standard care with or without br-ac: top-line results
items: Comparison of intact fish-skin graft to standard of care for treatment of venous leg ulcers using real-world data from the USWR with 1:1 matching on 14 wound/patient factors
items: A retrospective study on the outcomes of Mohs micrographic surgery for non-melanoma skin cancers (NMSC) using tri-layer amniotic membrane
items: A retrospective case series: CAMPs for complex non‑healing wounds
items: Cold atmospheric plasma: a new modality to treat chronic diabetic foot ulcers, venous leg ulcers, and pressure ulcers
items: https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/65
items: The biological imperative of cutaneous wounds: tissue repair
items: Clinical trials for cellular, acellular and matrix-like products (CAMPs): an evidence consensus
items: Regulatory and reimbursement reform for cellular, acellular, and matrix-like products (CAMPs)
items: Evaluating the efficacy of placental-derived allograft in managing non-healing pressure ulcers
items: Evaluation of dual layer amnion patch on the healing rate of chronic diabetic foot ulcers: an interim analysis of the Med-Maxx SG trial
items: Evaluation of acellular human dermis graft on the healing rate of chronic diabetic foot ulcers: an interim analysis of the Derm-Maxx trial
items: Real-world evaluation of cellular, acellular, and matrix-like products for pressure ulcers in the post-acute setting
items: A systematic review with semi-quantitative synthesis and GRADE qualification of the effectiveness of a keratin-based matrix in treating hard-to-heal wounds
items: Full thickness placental membrane allograft for diabetic foot ulcers: two clinical cases from the TIGERCAMP clinical trial
items: https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/53
items: https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/52
items: Evaluation of amnion chorion amnion placental allograft in the management of nonhealing diabetic foot ulcers and venous leg ulcers: a preliminary case series of the TIGERCAMP clinical trial
items: Evaluation of CompleteFTTM placental allograft in clinical practice across wound etiologies
items: A prospective, multicenter, randomized, controlled trial of non-healingdiabetic foot ulcers treated with standard care with or without br-ac: top-line results
items: https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/48
items: https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/46

Expert guidance for a pragmatic, evidence-based framework for skin substitutes (CTPs/CAMPs) across all chronic wound types
type: item
subject: Commentary
  topic: section
creator: Shaun Carpenter
creator: John Lantis
creator: Eric Lullove
creator: Ryan Dirks
creator: Abigail Chaffin
creator: Desmond Bell
creator: Marcus Gitterle
creator: Jonathan Johnson
creator: Kent Denmark
creator: Shawn Naqvi
creator: Todd Shaffett
creator: Angelina Ferguson
creator: Frank Aviles
creator: Elizabeth Faust
creator: Amanda Estapa
rights: Copyright (c) 2026 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2026-01-26
publication date: 2026-01-26
doi: 10.63676/yc3kfj17

Efficacy of a dehydrated porcine placental extracellular matrix for the treatment of multiple chronic wound types in a private practice model: a retrospective feasibility study
type: item
description: Objective: To assess real-world effectiveness of Innovamatrix™, a dehydrated porcine placental extracellular matrix (PPECM), in chronic wounds refractory to 30 days of optimized standard-of-care (SOC) therapy. Methods: Multicenter retrospective analysis of 72 chronic wounds (18 diabetic foot ulcers (DFUs), 4 venous leg ulcers (VLUs), 12 pressure injuries, 38 open wounds) in 66 patients treated with sequential PPECM applications (between October 2023 and June 2025). All wounds showed <50% area reduction during SOC run-in and met Medicare Local Coverage Determination (LCD) eligibility. Primary endpoint focused on complete re-epithelialization (99.99% to 100% percent area reduction (PAR)). Secondary endpoints included PAR, applications to closure, and time-to-closure. Results: Wounds presented with a mean baseline area of 9.75 ± 15.97 cm2 and achieved a mean PAR of 85.92%. Complete closure occurred in 46/72 wounds (63.9%): 61.1% of DFUs healed, 50.0% pressure injuries healed, 76.3% open wounds healed, and 0% VLUs healed. Among healed wounds, the median number of applications to closure was 6 (mean 6.28 ± 3.58) with open wounds healing the fastest (median 4). Paired t-test showed statistically significant area reductions (t(71)=10.47, p<0.001; Cohen’s d=0.65). Etiology-specific effect sizes were moderate to large. Kaplan-Meier median time-to-closure was 43 days (95% CI 36-56). Conclusion: In complex, previously non-responsive, chronic wounds, PPECM achieved a 63.9% complete closure rate and 85.92% mean PAR. Healing outcomes in pressure injuries and open wounds were comparable or superior to DFUs. These data support broader, etiology-agnostic use of PPECM as an effective advanced therapy when combined with comprehensive SOC.
subject: Articles
  topic: section
subject: porcine placental extracellular matrix
  topic: keywords
subject: chronic wound
  topic: keywords
subject: percentage area reduction
  topic: keywords
subject: complete closure
  topic: keywords
subject: Real-world evidence
  topic: keywords
creator: Daniel Kapp
creator: Shaun Carpenter
creator: Angelina Ferguson
creator: Kent Denmark
creator: Eric Lullove
creator: Michael Bain
creator: Shawn Naqvi
creator: Jordan Morrison
creator: Garrett Johnson
rights: Copyright (c) 2026 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2026-01-21
publication date: 2026-01-21
doi: 10.63676/1p43y632

Evaluation of intact fish skin grafts plus standard care in the treatment of venous leg ulcers: an interim analysis of the THOR trial
type: item
description: Background: Venous leg ulcers (VLUs) are nonhealing wounds that pose considerable clinical and economic challenges. Healing outcomes with existing standard-of-care (SOC) remain limited, creating a pressing need for more effective therapeutic options Methods: An interim analysis of this randomized controlled multicenter clinical trial evaluated intact fish skin graft (IFSG) and SOC versus SOC alone in nonhealing VLUs. The primary end-point was the percentage of target ulcers achieving complete wound closure in 12 weeks, defined as 100% re-epithelialization without drainage for two consecutive weeks, confirmed by blinded independent review. Results: The statistical analysis revealed that the treatment arm trended toward improved full wound closure at 12 weeks over SOC by 1.52 (credible interval: 1.37–2.22) in terms of relative risk (Treatment/SOC). This translates to an improvement of 8.53% (credible interval: 5.60%-19.7%) in percentage terms. In the ITT population, the IFSG + SOC arm achieved a 47.6% closure rate versus 21.7% with SOC alone, a 25.9% absolute gain that was not statistically significant (n = 21, 95% CI -0.02% to 0.493%, p = 0.07, α = 0.05). In the ITT and PP population, IFSG + SOC achieved a higher mean area reduction than SOC. Conclusion: The interim analysis demonstrated a positive trend favoring IFSG products over SOC alone. While the present interim analysis provides promising early results, limitations inherent to its preliminary nature warrant consideration. The alignment of these interim findings with the broader body of evidence reinforces biological plausibility and strengthens confidence that the final analysis will yield clinically meaningful results supported by high-quality evidence.
subject: Articles
  topic: section
subject: interim analysis
  topic: keywords
subject: venous leg ulcer
  topic: keywords
subject: chronic wounds
  topic: keywords
subject: tissue regeneration
  topic: keywords
subject: Cellular, acellular, and matrix-like products
  topic: keywords
creator: Thomas E Serena
creator: Brianna Tramelli
creator: Barkley Booker
creator: Emily King
creator: Dereck Shi
creator: John C Lantis
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/zf9c6s39

Update: CMS Final DFU/VLU CAMP LCDs Effective January 1, 2026: Covered, Cut, Status Quo, and Emerging Collateral Statutory Constraints
type: item
subject: Editorial
  topic: section
subject: Cellular, acellular, and matrix-like products
  topic: keywords
creator: William Tettelbach
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-12-19
publication date: 2025-12-19
doi: 10.63676/b9zfqh91

Evaluation of single layer amniotic membrane in the management of nonhealing diabetic foot ulcers: an interim analysis of CAMPX
type: item
description: Background: Diabetic foot ulcers (DFUs) represent a chronic and debilitating complication of diabetes, contributing substantially to patient morbidity, mortality, and economic burden. Despite advances in clinical management, outcomes with the current standard of care (SOC) remain suboptimal, with many ulcers failing to achieve complete closure. These limitations reinforce the need for innovative, cost-effective solutions that promote wound closure. Methods: This randomized controlled multicenter clinical trial evaluated the efficacy of single layer amniotic membrane (SLAM) plus SOC versus SOC alone in achieving complete closure of nonhealing DFUs over 12 weeks. The primary endpoint was complete wound closure, defined as 100% re-epithelialization without drainage for two consecutive weeks, confirmed by blinded independent review. Results: In Intent-To-Treat (ITT), the SLAM + SOC arm achieved a 13.1% closure rate versus 8.8% with SOC alone, with findings consistent in the Per-Protocol (PP) population. Additionally, the percent area reduction (PAR) from TV-1 to TV-13 measured weekly with digital photographic planimetry and physical examination were analyzed. For ITT, SLAM + SOC outperformed SOC on both average and median wound‐area reduction. Conclusion: The interim analysis demonstrated that wounds managed with SLAM products trended toward superiority over those managed with SOC.
subject: Articles
  topic: section
subject: interim analysis
  topic: keywords
subject: diabetic foot ulcer
  topic: keywords
subject: chronic wounds
  topic: keywords
subject: tissue regeneration
  topic: keywords
subject: clinical trial design
  topic: keywords
creator: Thomas E Serena
creator: Brianna Tramelli
creator: Emily King
creator: Dereck Shi
creator: Gregory Bohn
creator: Ryan Breisinger
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/m04r0s60

Real world evidence retrospective study to evaluate the safety and efficacy of an amniotic membrane allograft for venous leg ulcers in a post-acute care setting
type: item
description: Aims: To evaluate the reduction of wound size in venous leg ulcers (VLUs) after amniotic membrane allograft (AmnioBurgeon (OneBiotech, USA)) treatment. Methods: Single-center retrospective database study of patients treated with an amniotic membrane allograft for VLUs. Wound area was measured prior to each allograft application, and the change in wound area after each application was evaluated over the progression of therapy. Results: In total, 38 patients with 43 VLUs were treated weekly with AmnioBurgeon with an average wound size of 9.4 cm2. During the treatment course, 6% of the wounds completely healed with a mean time to healing of 38.8 days. 46% of the wounds partially healed with at least 50% or greater area reduction within 17.6 days on average. By the 4th week, 42% of wounds achieved 50% or more reduction in their size. Our treatment group included VLUs ranging between 0.25 cm2 and 25 cm2, achieving significant wound area reduction, indicating wound healing trajectory. Conclusion: Amniotic membrane allograft is an effective treatment for VLUs.
subject: Articles
  topic: section
subject: chronic wound
  topic: keywords
subject: wound healing
  topic: keywords
subject: Cellular, acellular, and matrix-like products
  topic: keywords
subject: venous leg ulcer
  topic: keywords
subject: amniotic membrane allograft
  topic: keywords
creator: Ayesha Qadeer
creator: Emaad Basith
creator: Martha R Kelso
creator: Saad Mohsin
creator: Rashad Sayeed
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/njqm6t61

Evaluation of lyophilized human amnion/chorion membrane (LHACM) in the management of nonhealing diabetic foot ulcers: an interim analysis of the CAMPAIGN trial
type: item
description: Background: Diabetic foot ulcers (DFUs) are chronic wounds that contribute significantly to morbidity, mortality, and healthcare costs. Despite current standard-of-care (SOC) approaches, healing rates re-main suboptimal, emphasizing the urgent need for innovative and cost-effective treatment options. Methods: An interim analysis of this multicenter, prospective, randomized controlled platform clinical trial evaluated the efficacy of multiple lyophilized human amnion/chorion membrane (LHACMs) with SOC versus SOC alone. The primary endpoint was percentage of target ulcers achieving complete wound closure in 12 weeks, defined as 100% re-epithelialization without drainage for two consecutive weeks, confirmed by blinded independent review. Results: The statistical analysis revealed that the treatment arm improved full wound closure at 12 weeks over SOC by 2.6 (credible interval: 0.81 – 5.0) in terms of relative. The estimated probability of complete wound closure under SOC was 23% (6.5%–42%), compared with 47% (37%–59%) under the treatment arm. This corresponds to a posterior absolute difference of 24% (4%–43%). This suggests a posterior probability advantage of 98.5% for LHACM. Conclusion: The interim analysis revealed that the placental membranes products trended to-ward superiority over SOC. Bayesian posterior estimates indicated 98.5% higher probabilities of wound closure and improved healing trajectories in the treatment group. These interim data provide early evidence of clinical benefit, subject to confirmation with full trial completion.
subject: Articles
  topic: section
subject: interim analysis
  topic: keywords
subject: diabetic foot ulcer
  topic: keywords
subject: chronic wounds
  topic: keywords
subject: tissue regeneration
  topic: keywords
subject: Cellular, acellular, and matrix-like products
  topic: keywords
creator: Thomas E Serena
creator: Brianna Tramelli
creator: Brittany Bonafide
creator: Zwelithini Tunyiswa
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/tk3kw419

A prospective, multicenter, randomized, controlled trial of non-healing diabetic foot ulcers treated with standard care with or without br-ac: top-line results
type: item
description: Aims: The primary objective of this randomized controlled trial was to determine whether non-ischemic, non-infected Wagner Grade 1-2 diabetic foot ulcers (DFUs) treated with standard care plus BioRetain Amniochorion (BR-AC) resulted in a higher probability of complete wound closure compared to standard care alone. Methods: Following a two-week run-in and stratified randomization, subjects attended clinic weekly for 12 weeks or until complete healing was observed. At each visit the wound was measured, debrided as needed, evaluated for infection and treated with or without BR-AC, followed by application of a non-adherent wound contact layer, a foam pad, alginate or hydrofiber dressing for moderately draining wounds, and a secondary retention bandage, including a standardized off-loading device. Bayesian statistics were used to evaluate the likelihood of healing. Results: The Intent to Treat (ITT) analysis showed a posterior mean absolute difference in healing rates between treatment and control of 0.22 (95% CrI: –0.01 to 0.45), with a 96.8% posterior probability that the effect exceeds zero and a posterior mean risk ratio of 1.9 (95% CrI: 0.87–3.2). The posterior mean probability of closure was 0.31 (95% CrI: 0.15–0.47) for the standard of care (SOC) arm (3% higher than the prior probability) compared with 0.53 (95% CrI: 0.34–0.74) for the treatment arm (18% higher than the prior probability). The treatment distribution was centered substantially higher, with limited overlap between intervals. The SOC arm showed a 36.4% posterior probability of closing by more than 50% at 12 weeks, compared with a 56.4% posterior probability for the treatment arm. Conclusion: This is the first controlled DFU trial examining a birth tissue product prepared using the ‘Bioretain’ method designed to retain integrity and contents. With only a 3.2% probability that BR-AC is not superior to SOC, these results provide strong evidence of treatment benefit.
subject: Articles
  topic: section
subject: Diabetic Foot, Foot Ulcer, Amniotic Membrane, Randomized Controlled Trial
  topic: keywords
creator: Nick McCoy
creator: Wendy Weston
creator: Zwelithini Tunyiswas
creator: Herbert Slade
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/qpavmd61

Comparison of intact fish-skin graft to standard of care for treatment of venous leg ulcers using real-world data from the USWR with 1:1 matching on 14 wound/patient factors
type: item
description: Background: Venous leg ulcers (VLUs) impose substantial morbidity and Medicare spending, yet many real-world ulcers remain refractory to standard of care (SOC). Intact fish-skin graft (IFSG) is a biologic graft used for chronic (hard-to-heal) wounds. We evaluated the comparative effectiveness of IFSG versus SOC in routine practice using a specialty wound registry with real world evidence design features intended to minimize bias. Methods: We performed a retrospective, target-trial–emulating, 1:1 propensity score–matched comparative-effectiveness study within the U.S. Wound Registry (USWR). Matching used 14 pre-specified patient- and wound-level covariates (including mobility as a measure of frailty and number of concomitant wounds). Results: The matched cohort included 129 IFSG-treated VLUs and 129 SOC-treated VLUs. Baseline balance was excellent by standardized mean differences; small residual differences favored SOC; IFSG wounds were older and trended larger. Healing occurred in 85.3% of IFSG wounds (110/129) versus 75.2% of SOC wounds (97/129); the absolute difference (+10.1%) was just below statistical significance (p=0.0801). SOC-treated VLUs increased in size on average more than IFSG-treated VLUs (p=0.0036). Conclusion: In a national wound registry with rigorous cohort construction, aligned index timing, comprehensive covariate control, and structured outcome capture, IFSG demonstrated favorable real-world effectiveness versus SOC for VLUs with a trend to-wards more healed wounds and a statistically significant lower average wound expansion. The high healing rate in the SOC arm is plausibly explained by baseline advantages (shorter duration, smaller area, and 'never-advanced-therapy' selection) as well as the absence of a set follow-up duration that typically extended until healing, a competing event, or administrative end of observation.
subject: Articles
  topic: section
subject: Venous leg ulcers; Real-World Evidence, chronic wounds; intact fish skin graft; tissue re-generation.
  topic: keywords
creator: Hongyu Miao
creator: Matthew Pine
creator: John C Lantis
creator: Caroline Fife
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/j0khvd18

A retrospective study on the outcomes of Mohs micrographic surgery for non-melanoma skin cancers (NMSC) using tri-layer amniotic membrane
type: item
description: Background: Non-melanoma skin cancers (NMSC), primarily basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), represent the most common malignancies worldwide. Mohs micrographic surgery (MMS) plays a crucial role in the management of these tumors, providing precise tumor clearance while maximizing the preservation of surrounding healthy tissue. Despite these advantages, post-surgical wound reconstruction for larger wounds and in specific anatomical locations can pose a challenge to the surgeon. Convex anatomic locations and poorly vascularized tissues (e.g., periosteum, cartilage, distal third of the lower extremities) may require months to heal. Healing time is influenced by wound size, depth, vascularity, and patient comorbidities. Cellular, acellular, and matrix-like products (CAMPs), such as tri-layered amniotic membrane (Amnio Tri-Core, Stability Biologics), have emerged as a promising reconstructive option. Objective: This retrospective study evaluated the clinical outcomes of patients undergoing MMS for the removal of NMSC. The post-surgical wounds were reconstructed using weekly applications of a tri-layered amniotic membrane. Analysis included time to complete closure and percentage wound area reduction (PAR). Methods: This multicenter study included 46 adult patients who underwent MMS for NMSC on regions such as the face, limbs, and neck. Patients with allergies to specific processing agents or incomplete records were excluded. Patients were divided into two groups: male (n=28) and female (n=18). The collected data included demographics, medical history, wound characteristics (type, location, and size), treatment details, and outcomes. Results: Complete closure was achieved in an average of 8.53 weeks. Conclusion: The results of this study suggest that wounds treated with tri-layer amniotic membrane after MMS can experience accelerated healing.
subject: Articles
  topic: section
subject: Non-melanoma skin cancer
  topic: keywords
subject: Basal cell carcinoma
  topic: keywords
subject: Squamous cell carcinoma
  topic: keywords
subject: Mohs micrographic surgery
  topic: keywords
subject: Wound reconstruction
  topic: keywords
subject: Biologic graft
  topic: keywords
subject: tri-layer amniotic membrane
  topic: keywords
subject: Healing time
  topic: keywords
creator: Neil Sandhu
creator: Thomas E Serena
creator: Bruna Nakayama
creator: Leandro Garcia
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-12-01
publication date: 2025-12-01
doi: 10.63676/yegme962

A retrospective case series: CAMPs for complex non‑healing wounds
type: item
description: Background: Chronic non‑healing wounds impose substantial clinical and economic burdens on patients and society. Patients with multiple comorbidities and risk factors are particularly vulnerable to developing wounds with delayed healing. Advanced wound care therapy such as cellular, acellular, and matrix‑like products (CAMPs) support wound healing when conservative treatment is insufficient. Results: Case 1 (91‑year‑old female, stage IV sacral ulcer): after wound‑bed preparation and 16 CAMP applications, surface area and volume reduced by 97% and 99%, respectively. Case 2 (74‑year‑old male, stage III sacral pressure ulcer while under treatment for pneumonia): 10 CAMP applications combined with negative pressure wound therapy (NPWT) achieved 70% surface area and 93% volume reduction; the patient subsequently died of pneumonia, unrelated to the wound. Case 3 (84‑year‑old female with dementia, venous leg ulcer with fat layer exposed): seven weekly CAMP applications with compression resulted in complete closure (100% reduction in area and volume). Case 4 (75-year-old female presented with an eight-year history of a chronic, non-pressure ulcer on the lower right leg with multiple ulcerations and sickle cell disease): 5 CAMP applications over 14 weeks achieving 100% healing. Case 5 (elderly male with pressure injury on lower right extremity: 10 CAMP applications with 100% wound healing. Conclusions: This case series exemplifies how advanced therapies such as CAMP treatment, in combination with standard of care treatment and patient compliance, results in substantial wound improvement and closure. Timely access for patients to receive CAMP therapy is essential to improve healing outcomes and improve quality of life measures.
subject: Articles
  topic: section
subject: wound healing
  topic: keywords
subject: pressure ulcer
  topic: keywords
subject: negative pressure wound therapy
  topic: keywords
subject: Cellular, acellular, and matrix-like products
  topic: keywords
subject: quality of life
  topic: keywords
creator: Ayesha Qadeer
creator: Emaad Basith
creator: Saad Mohsin
creator: Mena Piliin-Salgado
creator: Marie O'Connor
creator: Rashad Sayeed
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-11-24
publication date: 2025-11-24
doi: 10.63676/69fv4c62

Cold atmospheric plasma: a new modality to treat chronic diabetic foot ulcers, venous leg ulcers, and pressure ulcers
type: item
description: This study investigates the efficacy and safety of cold atmospheric plasma (CAP) in the treatment of 12 patients suffering from chronic wounds, focusing on diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and pressure ulcers. Chronic wounds represent a significant challenge in healthcare, often taking months to years to heal and imposing a substantial economic and quality of life burden on patients. CAP, an ionized gas at room temperature, is a source of reactive species, neutral particles, electromagnetic fields, and weak UV radiation. Its interaction with human cells stimulates wound healing processes, including cytokine release and angiogenesis, while exerting a bactericidal effect on prokaryotic cells. On average the 12 subjects had a percentage area reduction (PAR) of 21%, within the VLU group 60% of the subjects achieved a >40% PAR, and in the DFU group, 50% of the participants achieved a >40% PAR. Despite promising evidence from various studies, more data is needed to establish CAP as a standard treatment. This study contributes to the existing knowledge by evaluating the safety and effectiveness of CAP in treating long-standing and treatment-resistant ulcers. The study utilized the plasma care® device, a compact medical device that generates CAP using ambient air and energy. The plasma care® has shown notable efficacy in deactivating various bacteria and fungi, irrespective of antibiotic resistance.
subject: Articles
  topic: section
creator: Thomas E Serena
creator: Leandro Garcia
creator: Meghan Neil
creator: Laura Serena
creator: Michaela Wadsworth
creator: Colleen
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-11-14
publication date: 2025-11-14
doi: 10.63676/5waqaz41

https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/65
type: item
title: A multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of non-healing diabetic foot and venous leg ulcers (STABLECAMP)
description: Aims: To evaluate the efficacy of adjunct use of several cellular, acellular and matrix-like products (CAMPs) with standard of care (SOC), compared to SOC alone in the treatment of nonhealing diabetic foot ulcers (DFUs) or venous leg ulcers (VLUs) using a novel modified platform trial design. Methods: This is a multicentre, prospective, randomized controlled trial utilizing a modified platform design. Patients with non-healing DFUs or VLUs will be randomized into two groups: SOC alone or SOC plus several CAMPs; initial design is for up to 5 CAMPs per wound type, but the modified trial design can include additional CAMPs. The primary endpoint is complete wound closure within 12 weeks. Secondary outcomes include time to closure, percentage area reduction (PAR), patient-reported pain, adverse events, and quality of life, as measured by the Forgotten Wound Score and the Wound Quality of Life questionnaire. Exploratory objectives include assessment of offloading compliance and the proportion of subjects aged ≥65 years achieving complete wound closure. Results: The results will be reported following trial completion. Pooled results for DFUs and VLUs will be published separately, with a master publication for all pooled treatment arms vs pooled SOC arms. Conclusion: This trial is expected to provide high-quality efficacy data on several CAMPs used in addition to SOC and contribute to evidence-based practice in DFU and VLU management. The modified platform design offers a flexible and efficient approach to evaluating multiple interventions within a single clinical trial.
subject: Protocols
  topic: section
subject: Cellular, acellular, and matrix-like products
  topic: keywords
subject: Clinical trial protocol
  topic: keywords
subject: Foot ulcer, diabetic
  topic: keywords
subject: skin substitutes
  topic: keywords
creator: Thomas E Serena
creator: Siobhan McGurk
creator: Brianna Tramelli
creator: Emily King
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-11-14
publication date: 2025-11-14
doi: 10.63676/3csvta73

The biological imperative of cutaneous wounds: tissue repair
type: item
subject: Editorial
  topic: section
subject: Wound healing
  topic: keywords
creator: Daniel Kapp
creator: Abigail Chaffin
creator: Mervin Low
creator: Michael Desvigne
creator: Mark Suski
creator: Thomas E Serena
creator: Shaun Carpenter
creator: Thomas Davenport
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-11-12
publication date: 2025-11-12
doi: 10.63676/zsm44755

Clinical trials for cellular, acellular and matrix-like products (CAMPs): an evidence consensus
type: item
description: As Chair of the evidence consensus panel, I had the pleasure of convening the nation’s top experts in the field of wound healing on August 1, 2025, in Washington D.C.. The goals for the expert panel were twofold: 1) to address the evidence gap around the efficacy of cellular, acellular, and matrix-like products (CAMPs) in the treatment of nonhealing wounds and 2) to develop guidelines for the conduct of CAMP clinical trials. In 2024, the Medicare Administrative Contractors (MACs) published nearly identical Local Coverage Determinations (LCDs) requiring clinical trial evidence for reimbursement of CAMP products for diabetic foot and venous leg ulcers. The LCDs analyzed the available evidence for CAMPs and, based on their review, approved several products. After several delays, the MACs require products not on the list to submit peer-reviewed evidence submissions by November 1, 2025. I applaud CMS and the MACs for their reliance on clinical trial evidence; however, few of the patients enrolled in the approved RCTs published to date would meet the LCDs' requirements for medical necessity. Moreover, the LCDs do not provide any guidance on trial design or conduct to guide future research. The purpose of this evidence consensus is to define a practical, rigorous evidentiary bar spanning run-in requirements, consistent standard of care, pre-trial statistical analysis plans, validated clinical endpoints, complete datasets, and data transparency. In this way, investigators, sponsors, journals, and payers can align on what constitutes credible proof of benefit. The implications of publishing this consensus are immediate and material: it creates a uniform template for trials intended to support Medicare coverage, improves comparability across products, reduces bias and opaque practices, and prioritizes outcomes that matter to patients and clinicians. By articulating standards that reflect current best practice and analytic methods, this consensus gives CMS and the MACs a defen…
subject: Articles
  topic: section
creator: Thomas E Serena
creator: Charles Andersen
creator: Gregory Bohn
creator: Greg Cosentino
creator: Matthew Davis
creator: Michael Desvigne
creator: Arshdeep Kaur
creator: Mervin Low
creator: Alisha Oropallo
creator: Lou Roselli
creator: Chris Sabatino
creator: Richard Simman
creator: Bert Slade
creator: Zweli Tunyiswa
creator: Naz Wahab
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-11-07
publication date: 2025-11-07
doi: 10.63676/r8d7vm21

Regulatory and reimbursement reform for cellular, acellular, and matrix-like products (CAMPs)
type: item
description: In August 2025, a national meeting was held in Washington, D.C., gathering 32 experts from across clinical, academic, manufacturing, legal and policy sectors to address the clinical, regulatory, and economic landscape of CAMPs. This consensus document summarizes key discussions from that meeting and the panel recommendations are aimed at improving the regulatory and reimbursement environment for CAMPs in the U.S., while concurrently ensuring Medicare beneficiaries have equitable access to advanced therapies for wound healing and amputation avoidance.
subject: Articles
  topic: section
creator: William Tettelbach
creator: Daniel Kapp
creator: David G Armstrong
creator: Jonathan Johnson
creator: Jeffrey Niezgoda
creator: Ryan Dirks
creator: Michael Shin
creator: Stuart Oertli
creator: Bob Bartlett
creator: Martha R Kelso
creator: Robert Odell
creator: Salvatore Leo
creator: Garrett Grinsfelder
creator: Terrence Mabry
creator: Marshall Medley
creator: Michael Del Piano
creator: Howard Walthall
creator: Benjamin A Kimball
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-11-07
publication date: 2025-11-07
doi: 10.63676/wjhaj519

Evaluating the efficacy of placental-derived allograft in managing non-healing pressure ulcers
type: item
description: Background: Chronic wounds such as pressure ulcers (PUs) cause physical, emotional and financial strain on patients. Amniotic membranes have been demonstrated in previous studies to aid wound closure. Methods: This study aims to examine the efficacy of cellular, acellular, and matrix-like products (CAMPs) in achieving complete closure of PUs that were not responsive to standard of care (SOC) treatment. Results: Overall, 25 subjects with 37 pressure ulcers that had failed to heal with 6 weeks of SOC were treated with three-layer placental derived allograft (TLPA) for up to 16 weeks. Mean age was 69.3 years, 16 patients were female, and 9 were male. At baseline prior to intervention, mean wound size was 44.9cm2 (SD 103.5) and three (8.1%) PUs achieved 40% or greater percent area reduction (PAR). At the end of TLPA treatment, 33 (89.2%) of PUs had a PAR of 40% or greater. Conclusion: TLPA treatment was shown to achieve 40% or more wound area reduction in this cohort of 25 subjects with 37 PUs that had not responded to SPC. The observed rate of improvement supports further investigation of TLPA in prospective controlled studies to validate efficacy, assess time to closure, and determine cost-effectiveness for PUs.
subject: Articles
  topic: section
subject: diabetic foot ulcer
  topic: keywords
subject: chronic wounds
  topic: keywords
subject: tissue regeneration
  topic: keywords
subject: clinical trial design
  topic: keywords
creator: Thomas E Serena
creator: Siobhan McGurk
creator: Emily King
creator: Brianna Tramelli
creator: Dereck shi
creator: Kristy Breisinger
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-11-01
publication date: 2025-11-01
doi: 10.63676/1bzgbv82

Evaluation of dual layer amnion patch on the healing rate of chronic diabetic foot ulcers: an interim analysis of the Med-Maxx SG trial
type: item
description: Background: Diabetes often results in persistent and expensive complications, including diabetic foot ulcers (DFUs), which result in substantial morbidity and mortality. Despite compliance with standard of care (SOC) protocols, healing remains inadequate, emphasizing the need for novel and economically sustainable therapies. Methods: This interim analysis of a multi-center, open label, randomized controlled trial evaluated the efficacy of dual layer amnion patch (DLAP; Amnio-Maxx®, Royal Wound-X, Hackensack, NJ 07601, USA) on chronic DFU closure. Primary endpoints were complete closure at 12-weeks and percentage area reduction (PAR). Interim data were reviewed for this analysis. Fi-nal database lock and quality control checks were pending. Uncertainty was propagated using a Bayesian approach to provide credible estimates despite the provisional data status. Results: Probability of wound closure at week 12 was 4% (94% credible interval: 0.004%-12%) under SOC and 35% (94% CI: 17%-54%) under DLAP, corresponding to an absolute improvement of 31% (94% CI: 12%-48%) and a risk ratio of 41 (94% CI: 1.2 to 115). This indicates a 99.9% posterior probability that DLAP improves wound closure compared with SOC. At week 12, mean PAR was 75% (94% credible interval: 50%-95%) for SOC only, and 73% (94% CI: 47%-95%) for DLAP. The absolute difference in PAR is 2.4% (94% CI: −35%-39%). Conclusion: DFUs treated with DLAP were more likely to reach full closure by week 12. Remaining open wounds were more resistant to shrinkage, resulting in lower mean PAR among non-closers; SOC patients were more frequently “partially healed”, showing large proportional area reductions without closure. Closure and PAR results are consistent and complementary: DLAP increases the probability of full closure, while SOC patients frequently remain partially closed with continued wound area reduction.
subject: Abstracts
  topic: section
creator: Thomas E Serena
creator: Brianna Tramelli
creator: Zwelithini Tunyiswa
creator: Nicole Schrecengost
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/atwn7717

Evaluation of acellular human dermis graft on the healing rate of chronic diabetic foot ulcers: an interim analysis of the Derm-Maxx trial
type: item
description: Background: Diabetic foot ulcers (DFUs) remain a chronic and costly complication of diabetes, associated with morbidity and mortality. Healing outcomes are often suboptimal, despite compliance with standard of care (SOC) protocols, highlighting the need for innovative and cost-effective therapeutic approaches. Methods: This interim analysis of a multi-center, open label, randomized controlled trial evaluated the efficacy of acellular human dermis graft (AHDG; Derm-Maxx™, Royal Wound-X, Hackensack, NJ 07601, USA) on chronic DFU closure. Primary endpoints were complete closure at 12-weeks and percentage area reduction (PAR). Interim data were reviewed for this analysis. Final database lock and quality control checks were pending. Uncertainty was propagated using a Bayesian approach to provide credible estimates despite the provisional data status. Results: The probability of wound closure at week 12 was 19% (94% credible interval: 6.3%-32%) with SOC, and 45% (94% CI: 33%-57%) with AHDG, representing an absolute improvement of 27% (94% CI: 13%-41%) and a risk ratio of 2.8 (94% CI: 1.2 to 4.9). This indicates a 99.9% posterior probability that AHDG improves closure compared with SOC. At week 12, mean PAR was 85% (94% credible interval: 72%-97%) for SOC only wounds versus 66% (94% CI: 38%-91%) for wounds in the AHDG arm. The absolute difference in PAR is 19% (94% CI: 12%-49%). Conclusion: Wounds in the AHDG arm were more likely to achieve complete closure by week 12. Remaining open wounds exhibited slower closure, resulting in lower mean PAR among non-closers. Additionally, wounds in the SOC group more frequently remained “partially closed,” with continued but incomplete area reduction. Closure and PAR outcomes are consistent and complementary, indicating that AHDG enhances the likelihood of complete wound closure in comparison to SOC only.
subject: Abstracts
  topic: section
creator: Thomas E Serena
creator: Brianna Tramelli
creator: Zwelithini Tunyiswa
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/3ddgch87

Real-world evaluation of cellular, acellular, and matrix-like products for pressure ulcers in the post-acute setting
type: item
description: Objective: To evaluate the real-world effectiveness of cellular, acellular, and matrix-like products (CAMPs) compared with standard of care (SOC) in promoting pressure ulcer (PU) healing among patients treated in post-acute settings. Method: This observational comparative effectiveness study analyzed de-identified data from the LiftOff Registry, a national database encompassing more than 18,000 patients and 23,000 pressure ulcers (PUs) treated in long-term acute care hospitals and skilled nursing facilities. Wounds receiving CAMPs + SOC were compared with those managed with SOC alone. Bayesian propensity score methods were applied to reduce confounding and achieve covariate balance across key demographic and clinical variables. All Bayesian models were implemented in Python 3.12 using PyMC, with the Bayesian Model-Building Interface (Bambi) for model specification and ArviZ for posterior diagnostics and visualization. Healing—defined as complete re-epithelialization or closure—was modeled using Bayesian logistic regression with study arm and baseline wound stage as predictors, summarized as posterior means and 95% credible intervals (CrI). Results: Before matching, the SOC cohort included 9,356 patients (14,740 wounds), while the CAMPs cohort included 136 patients (190 wounds). After Bayesian matching, 375 wounds were retained (190 treatment; 185 SOC), with comparable distributions of age, diabetes prevalence, and baseline wound area (mean: 23.2cm² versus 24.4cm²). Most wounds were classified as Stage 3 or 4. The posterior mean average treatment effect (ATE) was 0.16 (95% CrI, 0.15 –0.18), representing a 16-percentage-point improvement in ATE with CAMPs versus SOC, or approximately a 50 point increase in percentage terms. Conclusion: The use of CAMPs in post-acute settings was associated with a significant and credible improvement in PU healing compared with SOC. These real-world findings support the integration of CAMPs into post-acute wound management protocols to…
subject: Abstracts
  topic: section
creator: ZWELITHINI TUNYISWA
creator: Ryan Dirks
creator: Howard Walthall
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/61n5qp09

A systematic review with semi-quantitative synthesis and GRADE qualification of the effectiveness of a keratin-based matrix in treating hard-to-heal wounds
type: item
description: Background: Hard-to-heal wounds impose substantial morbidity, cost, and, in the case of diabetic foot ulcers, elevated mortality risk. Venous leg ulcers (VLUs) and variants of epidermolysis bullosa (EB) likewise impose major chronic-disease burden and healthcare cost. Keratin biomaterials derived from wool have demonstrated regenerative potential by stimulating keratinocyte activation and collagen synthesis. Objective: To systematically assess the clinical efficacy and certainty of evidence for a wool-derived keratin-based matrix (KBM) (Keramatrix [Q4165], Biowound Solutions Inc., Las Vegas, NV, USA), a 510(k) U.S. Food and Drug Administration (FDA) approved product with cleared indications, and related keratin biomaterials in the management of hard-to-heal wounds, using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. Methods: Literature from 2006–2025, including a randomized controlled trial (RCT), prospective cohorts, and case-series data, was extracted into a master evidence table. Studies were assessed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020) and evaluated across five GRADE domains with appropriate downgrading and upgrading factors. Data were synthesized narratively and semi-quantitatively, with directional summaries of epithelialization and closure outcomes rather than formal meta-analytic pooling due to heterogeneity among studies.Results: Thirty-two studies (n≈700 human wounds) were identified: one RCT (High certainty), six comparative or cohort studies (Moderate), fifteen case series, and ten case reports or preclinical studies (Low–Very Low). Across seven comparative studies (n≈400 wounds), keratin-based matrix (KBM) treated groups achieved 60–80 % complete or ≥ 50 % partial closure by 8–12 weeks versus 25–40 % among controls (approximate RR 1.97; 95 % CI 1.2–3.2). This finding, based on a fixed-effect inverse-variance summary of study-level risk ratios,…
subject: Abstracts
  topic: section
creator: William Tettelbach
creator: Martha R Kelso
creator: Louis Cappa
creator: Mervin Low
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/v1rzsg82

Full thickness placental membrane allograft for diabetic foot ulcers: two clinical cases from the TIGERCAMP clinical trial
type: item
description: Background: Diabetic foot ulcers (DFUs) are chronic wounds often marked by delayed epithelialization and limited response to standard of care (SOC) procedures. Their persistence substantially impairs quality of life and are associated with 50-60% infection rates and around 30% 5-year mortality rates, highlighting the need for new cost-effective strategies. Methods: This case series evaluated two subjects with chronic DFUs evaluated at 2 sites between April 2025 and July 2025. Offloading was provided with a removable walker boot. Subjects had target ulcers between >1.0 cm2 and 20.0 cm2 at enrollment that had not closed after 4 weeks of SOC. Subjects received a weekly application of a full-thickness placental membrane allograft (FT; caregraFT™, Tiger Wound Care Medical, LLC, Conshohocken, PA, USA) combined with standard care (sharp debridement, offloading, and moisture balance) in an ongoing randomized con-trolled modified platform trial. Results: The two patients were between the ages of 79 and 86, one female and one male. One patient reached ≥50%, ≥75%, and ≥90% PAR by Weeks 1, 3, and 6, respectively, with complete closure at Week 9. The other subject reached ≥50%, ≥75%, and ≥90% PAR by Weeks 2, 4, and 5, respectively, with complete closure at Week 8. Both wounds were confirmed closed in subsequent closure confirmation visits. No product related adverse events were reported. Conclusion: These cases demonstrate the potential of FT allografts in aiding SOC to improve wound closure rates of DFUs in older patients with both hard-to-heal and newly diagnosed chronic wounds. These results highlight the importance of continued clinical evaluation through controlled studies aimed at confirming both the wound care benefits and the potential for reducing overall healthcare costs.
subject: Abstracts
  topic: section
creator: Thomas E Serena
creator: Ekaterina Chashnikova
creator: Brianna Tramelli
creator: Emily King
creator: Dereck Shi
creator: Gregory Bohn
creator: Henry Ohse
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/t0a6qp70

https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/53
type: item
title: A multicenter, prospective randomized controlled modified dual platform trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers (TIGERCAMP)
description: Aim: To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design. Methods: This multicenter, prospective, randomized controlled trial employs a modified plat-form design. Patients with, nonhealing DFUs or VLUs will be randomized to receive either SOC alone or SOC in combination with one of multiple CAMPs. The initial phase will evaluate two CAMPs for each ulcer type: amnion chorion amnion placental allograft (ACA; ACAPatch™, Tiger Wound Care Medical, LLC, Conshohocken, PA, USA) and full-thickness placental membrane al-lograft (FT; caregraFT™, Tiger Wound Care Medical, LLC, Conshohocken, PA, USA). However, the modified platform design allows for subsequent inclusion of additional CAMPs. The primary endpoint is complete wound closure within 12 weeks. Secondary endpoints include time to clo-sure, percentage wound area reduction, number of adverse events, change in patient reported pain, and average number of placental allografts used. Exploratory endpoints include change in patient quality of life, percent of target ulcers achieving complete closure for patients 65 years of age or older, and change in functional ambulation. Results: Upon completion of the trial, results will be reported in accordance with the study pro-tocol. Separate pooled analyses for DFUs and for VLUs will be published. Additionally, a master publication for all pooled product arms vs pooled SOC arms will be completed. Conclusion: This trial is anticipated to provide efficacy data on multiple CAMPs used as ad-juncts to SOC, thereby strengthening evidence-based practice in DFU and VLU management. The modified platform design provides a flexible and efficient model to evaluate multiple interven-tions within a single trial.
subject: Abstracts
  topic: section
creator: Thomas E Serena
creator: Brianna Tramelli
creator: Emily King
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/njbsev63

https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/52
type: item
title: Evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care in the management of non-healing pressure ulcers using matched controls: a randomized controlled modified platform trial
description: Aim: To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC (mSOC) over 20 weeks using a modified platform trial design. Methods: This randomized controlled modified platform trial is designed to assess the efficacy of cellular, acellular, and matrix-like products alongside SOC in the closure of pressure ulcers. The trial will initially review two CAMPs: amnion chorion amnion placental allograft (ACA; ACApatch™, Tiger Wound Care Medical, LLC, Conshohocken, PA, USA) and full-thickness placental mem-brane allograft (FT; caregraFT™, Tiger Wound Care Medical, LLC, Conshohocken, PA, USA). However, the modified platform design allows for additional products to be included with protocol amendment. All enrolled patients will be matched on key demographic and clinical factors to ensure group comparability, minimize bias, and strengthen the validity of care effect comparisons. The primary endpoint is the percentage of target ulcers achieving complete wound closure over 20 weeks. Secondary endpoints include time to closure, percentage wound area reduction, number of adverse events, change in quality-of-life, and average number of placental allografts used. Exploratory endpoint is percentage of target ulcers achieving complete wound closure for subjects 65 years of age or older. Results: At the conclusion of the trial, study findings will be reported in accordance with the approved protocol. Conclusion: This trial is anticipated to provide efficacy data on multiple CAMPs used in concurrence with SOC, improving evidence-based practice for pressure ulcer management. The modified platform design provides a flexible model to evaluate multiple interventions within a single trial. The use of mSOC as the control arm allows for unbiased comparisons and enhances reliability of observed treatment effects.
subject: Abstracts
  topic: section
creator: Thomas E Serena
creator: Brianna Tramelli
creator: Emily King
creator: Ekaterina Chashnikova
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/kejtjc97

Evaluation of amnion chorion amnion placental allograft in the management of nonhealing diabetic foot ulcers and venous leg ulcers: a preliminary case series of the TIGERCAMP clinical trial
type: item
description: Background: Diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) are chronic wounds that often demonstrate delayed closure and limited response to standard-of-care (SOC) procedures. Their persistence impacts quality of life and leads to elevated morbidity, mortality, and healthcare expenditures. The limited effectiveness of current management approaches highlights the need for additional, innovative, and cost-effective strategies. Methods: This case series of 2 patients with VLU and 1 patient with a DFU were evaluated at 3 sites between May 2025 and August 2025. Eligible subjects had target ulcers between >1.0 cm2 and 20.0 cm2 at enrollment that had not closed after 4 weeks of SOC. Subjects received a topical application of the amnion chorion amnion placental allograft (ACA; ACAPatch™, Tiger Wound Care Medical, LLC, Conshohocken, PA, USA) in addition to SOC for up to 12 weeks or until com-plete (100%) wound closure. Wounds were measured by digital imaging at baseline and each weekly visit. Safety and tolerability were monitored throughout. Results: All patients were female, age ranged from 59 - 82 years, with baseline wounds 7.0, 9.4, and 2.3 cm² (mean 6.2; SD 2.9). Cumulative PAR milestones (≥50/≥75/≥90) were achieved by Weeks 1/2/4, 4/6/8, and 1/3/8, respectively, with complete closure at Weeks 5, 9, and 12; closures were confirmed at a subsequent closure confirmation visit. Progressive granulation and epithelialization were observed in all cases. No product-related adverse events were reported. Conclusion: Preliminary findings indicate ACApatch™ may aid SOC in advancing wound clo-sure rates in chronic DFUs and VLUs unresponsive to SOC alone. Results support continued evaluation in controlled studies to confirm efficacy and cost-effectiveness.
subject: Abstracts
  topic: section
creator: Thomas E Serena
creator: Siobhan McGurk
creator: Brianna Tramelli
creator: Emily King
creator: Dereck Shi
creator: Gregory Bohn
creator: Henry Ohse
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/t232c553

Evaluation of CompleteFTTM placental allograft in clinical practice across wound etiologies
type: item
description: Aim: The complex nature of chronic wounds requires care that is not limited to general Standard of Care (SoC) approaches like debridement, wound dressings, negative pressure therapy, hyperbaric oxygen therapy, and of the like. Cellular, acellular, and matrix-like products (CAMPs), such as amniotic membranes, are a prospective solution to these challenges. A growing body of efficacy and safety evidence suggests placental derived allografts have successfully been applied alongside SoC in heterogenous populations with complex comorbidities. The present analysis examines wound closure performance across wounds of varying pathologies characterized by prior lack of improvement under SoC alone. Methods: In this single-center retrospective study, wound size and associated duration of closure was analyzed. During each visit, care consisted of debridement followed by application of the full-thickness placental allograft, CompleteFT. Wound characteristics and size measurements were captured prior to allograft application. Dimension analysis was conducted to evaluate wound closure efficacy over time. Results: A total of 7 wounds across 5 patients (Male: 4, Female: 1) were analyzed as part of this study; etiologies include venous ulcers (n=3), pressure ulcers (n=1) and Mohs defects (n=2). Cumulatively, wounds showed a consistent Percent Area Reduction over time, with 100% wound closure observed for all patients post final allograft application. High coefficients of determinations, ranging from 0.77 to 0.97, per wound further indicates consistent size attenuation overtime until complete closure was reached. Conclusions: Findings indicate that full-thickness placental allografts, such as CompleteFT, are an effective, less invasive application which can support wound closure across multiple wound types. Implementing these supportive allografts within wound care could result in improved patient quality-of-life and cost savings while decreasing clinic visits, complications like infec…
subject: Abstracts
  topic: section
creator: Naz Wahab
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/nfxw9n34

A prospective, multicenter, randomized, controlled trial of non-healingdiabetic foot ulcers treated with standard care with or without br-ac: top-line results
type: item
description: Aims: The primary objective of this randomized controlled trial was to determine whether non-ischemic, non-infected Wagner Grade 1-2 diabetic foot ulcers (DFUs) treated with standard care plus BioRetain Amniochorion (BR-AC) resulted in a higher probability of complete wound closure compared to standard care alone. Methods: Following a two-week run-in and stratified randomization, subjects attended clinic weekly for 12 weeks or until complete healing was observed. At each visit the wound was measured, debrided as needed, evaluated for infection and treated with or without BR-AC, followed by application of a non-adherent wound contact layer, a foam pad, alginate or hydrofiber dressing for moderately draining wounds, and a secondary retention bandage, including a standardized off-loading device. Bayesian statistics were used to evaluate the likelihood of healing. Results: The Intent to Treat (ITT) analysis showed a posterior mean absolute difference in healing rates between treatment and control of 0.22 (95% CrI: –0.01 to 0.45), with a 96.8% posterior probability that the effect exceeds zero and a posterior mean risk ratio of 1.9 (95% CrI: 0.87–3.2). The posterior mean probability of closure was 0.31 (95% CrI: 0.15–0.47) for the standard of care (SOC) arm (3% higher than the prior probability) compared with 0.53 (95% CrI: 0.34–0.74) for the treatment arm (18% higher than the prior probability). The treatment distribution was centered substantially higher, with limited overlap between intervals. The SOC arm showed a 36.4% posterior probability of closing by more than 50% at 12 weeks, compared with a 56.4% posterior probability for the treatment arm. Conclusion: This is the first controlled DFU trial examining a birth tissue product prepared using the ‘Bioretain’ method designed to retain integrity and contents. With only a 3.2% probability that BR-AC is not superior to SOC, these results provide strong evidence of treatment benefit.
subject: Abstracts
  topic: section
creator: Herbert Slade
creator: Nick McCoy
creator: Wendy W Weston
creator: Zwelithini Tunyiswa
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/9mz36k56

https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/48
type: item
title: Comparative outcomes of a placenta-based tissue product to other LCD covered cellular and matrix-based products for the treatment of lower extremity diabetic ulcers: A Medicare real world evidence study
description: Objective: To compare clinical and economic outcomes of the Artacent placental allograft to 18 other covered cellular and matrix-based products (CAMPs) using data from a Medicare database.Methods: We conducted a retrospective cohort study using data from the Centers for Medicare and Medicaid Services (CMS), employing a 1:1 matching procedure based on six pre-specified baseline covariates for Medicare patients who received Artacent or 18 other covered CAMPs for the treatment of lower extremity diabetic ulcer (LEDUs)between 2020 and 2023. LEDU episodes were constructed from claims data by linking sequential services until a 60-day clean period without LEDU related claims was observed, which signified the end of an episode. Outcomes assessed within each completed episode included major and minor amputations, as well as emergency department visits, hospital readmissions, or care transitions to other sites of service.Results: A total of 2,226,571 episodes were identified in the CMS database, of which 1,192 LEDU episodes (596 in each cohort) met the study eligibility criteria and were analyzed. Rate of major and minor amputation in the Artacent group was 2.7% and 13.6% respectively as compared to 3.4% and 14.8% in the pooled CAMP group (p = 0.498 and 0.561 respectively). Visits or re-admissions to a hospital were also lower in the Artacent group; however, the results were not statistically significant. Conclusion: Analysis of CMS data revealed similar outcomes when comparing Artacent placental allograft to 18 other covered CAMPs available on the market. It is reasonable to conclude that Artacent may be integrated into the treatment paradigms for LEDUs.
subject: Abstracts
  topic: section
creator: William Tettelbach
creator: Travis Tucker
creator: Kimberly Kot
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/en9cer34

Evaluation of intact fish skin grafts plus standard care in the treatment of venous leg ulcers: an interim analysis of the THOR trial
type: item
description: Background: Venous leg ulcers (VLUs) are nonhealing wounds that pose considerable clinical and economic challenges. Healing outcomes with existing standard-of-care (SOC) remain limited, creating a pressing need for more effective therapeutic options Methods: An interim analysis of this randomized controlled multicenter clinical trial evaluated intact fish skin graft (IFSG) and SOC versus SOC alone in nonhealing VLUs. The primary end-point was the percentage of target ulcers achieving complete wound closure in 12 weeks, defined as 100% re-epithelialization without drainage for two consecutive weeks, confirmed by blinded independent review. Results: The statistical analysis revealed that the treatment arm trended toward improved full wound closure at 12 weeks over SOC by 1.52 (credible interval: 1.37–2.22) in terms of relative risk (Treatment/SOC). This translates to an improvement of 8.53% (credible interval: 5.60%-19.7%) in percentage terms. In the ITT population, the IFSG + SOC arm achieved a 47.6% closure rate versus 21.7% with SOC alone, a 25.9% absolute gain that was not statistically significant (n = 21, 95% CI -0.02% to 0.493%, p = 0.07, α = 0.05). In the ITT and PP population, IFSG + SOC achieved a higher mean area reduction than SOC. Conclusion: The interim analysis demonstrated a positive trend favoring IFSG products over SOC alone. While the present interim analysis provides promising early results, limitations inherent to its preliminary nature warrant consideration. The alignment of these interim findings with the broader body of evidence reinforces biological plausibility and strengthens confidence that the final analysis will yield clinically meaningful results supported by high-quality evidence.
subject: Abstracts
  topic: section
creator: Thomas E Serena
creator: Brianna Tramelli
creator: Barkley Booker
creator: Emily King
creator: Dereck Shi
creator: John C Lantis
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/2dvh2b04

https://internationaljournaloftissuerepair.com/index.php/ijtr/article/view/46
type: item
title: Evaluation of multiple cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the treatment of nonhealing diabetic foot ulcers: an interim analysis of the CAMPFIRE clinical trial
description: Background: Characterized by chronic duration and impaired healing, diabetic foot ulcers (DFUs) impose significant burdens in terms of morbidity, mortality, and economic cost. The limited effectiveness of current standard of care (SOC) approaches highlights the need for novel and cost-effective therapeutic strategies. Methods: An interim analysis of this multicenter, prospective, randomized controlled modified platform trial evaluated efficacy of multiple cellular, acellular, and matrix-like products (CAMPs) plus SOC versus SOC alone in achieving complete closure of hard-to-heal DFUs in 12-weeks. Results: Due to the early stage of this trial, percent area reduction at four weeks was used as a measure of success. For the dual layer matrix (Complete AA, Samaritan Biologics, LLC, Cordova, TN, USA) the PAR at 4 weeks was -15.3% compared to SOC at -11.1%. For the perforated tri-layer graft (MOST, Samaritan Biologics, LLC, Cordova, TN, USA) the PAR at 4 weeks was -32.5% compared to the -11.1% for SOC. Conclusion: This interim analysis demonstrates favorable treatment effect for CAMPs compared to SOC alone.
subject: Abstracts
  topic: section
creator: Thomas E Serena
creator: Brianna Tramelli
creator: Stephanie Wilkins
creator: Zwelithini Tunyiswa
rights: Copyright (c) 2025 International Journal of Tissue Repair https://creativecommons.org/licenses/by-nc-nd/4.0
date: 2025-10-31
publication date: 2025-10-31
doi: 10.63676/t90w0b82