Real world evidence retrospective study to evaluate the safety and efficacy of an amniotic membrane allograft for lower extremity diabetic ulcers in a post-acute care setting
DOI:
https://doi.org/10.63676/0m71qt93Keywords:
chronic wounds, wound healing, Cellular, acellular, and matrix-like products , lower extremity diabetic ulcer, amniotic membrane allograftAbstract
Aims: To evaluate the reduction of lower extremity diabetic ulcer (LEDU) wound size after amniotic membrane allograft (AmnioBurgeon (OneBiotech, LLC, USA) treatment.
Methods: Single center retrospective database review for patients treated with AmnioBurgeon for LEDUs. Wound area was measured prior to each allograft application and change in wound area over each application was evaluated over progression of therapy.
Results: In total, 24 patients with 28 LEDUs were treated weekly with AmnioBurgeon with average wound size of 17.4cm2. During the treatment course, 14% of the wounds completely healed with a mean time to healing of 77 days. Overall, 64% of them achieved partial closure with at least 50% area reduction within 21 days on average. By week 4, 46% of wounds achieved ≥50% reduction in their size.
Conclusion: Amniotic membrane allograft is an effective treatment for LEDUs which were not successful in healing with standard of care.
References
Deng X, Gould M, Ali MA. A review of current advancements for wound healing: Biomaterial applications and medical devices. J Biomed Mater Res B Appl Biomater. 2022;110(11):2542-2573. https://doi.org/10.1002/jbm.b.35086
Ozgok Kangal MK, Kopitnik NL. Physiology, Wound Healing. StatPearls. Treasure Island (FL) 2025. https://www.ncbi.nlm.nih.gov/books/NBK535406/ (accessed 30 October 2025)
Beckman JA, Creager MA. Vascular Complications of Diabetes. Circ Res. 2016;118(11):1771-1785. https://doi.org/10.1161/CIRCRESAHA.115.306884
Falanga V, Isseroff RR, Soulika AM, et al. Chronic wounds. Nat Rev Dis Primers. 2022;8(1):50. https://doi.org/10.1038/s41572-022-00377-3
Bowers S, Franco E. Chronic Wounds: Evaluation and Management. Am Fam Physician. 2020;101(3):159-166.
Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023;330(1):62-75. https://doi.org/10.1001/jama.2023.10578
Wolny D, Štěpánek L, Horáková D, Thomas J, Zapletalová J, Patel MS. Risk Factors for Non-Healing Wounds-A Single-Centre Study. J Clin Med. 2024;13(4):1003. Published 2024 Feb 9. https://doi.org/10.3390/jcm13041003
Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. 2016;63(2 Suppl):3S-21S. https://doi.org/10.1016/j.jvs.2015.10.003
Vecin NM, Kirsner RS. Skin substitutes as treatment for chronic wounds: current and future directions. Front Med (Lausanne). 2023;10:1154567. Published 2023 Aug 29. https://doi.org/10.3389/fmed.2023.1154567
Protzman NM, Mao Y, Long D, et al. Placental-Derived Biomaterials and Their Application to Wound Healing: A Review. Bioengineering (Basel). 2023;10(7):829. https://doi.org/10.3390/bioengineering10070829
Serena TE, Yaakov R, Moore S, et al. A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers. J Comp Eff Res. 2020;9(1):23-34. https://doi.org/10.2217/cer-2019-0142
Zelen CM, Poka A, Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study. Foot Ankle Int. 2013;34(10):1332-1339. https://doi.org/10.1177/1071100713502179
Zelen CM, Serena TE, Gould L, et al. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. Int Wound J. 2016;13(2):272-282. https://doi.org/10.1111/iwj.12566
Zelen CM, Serena TE, Snyder RJ. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Int Wound J. 2014;11(2):122-128. https://doi.org/10.1111/iwj.12242
Schmiedova I, Dembickaja A, Kiselakova L, Nowakova B, Slama P. Using of Amniotic Membrane Derivatives for the Treatment of Chronic Wounds. Membranes (Basel). 2021;11(12):941. https://doi.org/10.3390/membranes11120941
Serena TE, Carter MJ, Le LT, Sabo MJ, DiMarco DT; EpiFix VLU Study Group. A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Wound Repair Regen. 2014;22(6):688-693. https://doi.org/10.1111/wrr.12227
Penny H, Rifkah M, Weaver A, et al. Dehydrated human amnion/chorion tissue in difficult-to-heal DFUs: a case series. J Wound Care. 2015;24(3):104-111. https://doi.org/10.12968/jowc.2015.24.3.104
Carter MJ. Dehydrated human amnion and chorion allograft versus standard of care alone in treatment of Wagner 1 diabetic foot ulcers: a trial-based health economics study. J Med Econ. 2020;23(11):1273-1283. https://doi.org/10.1080/13696998.2020.1803888
Shah P, Inturi R, Anne D, et al. Wagner’s Classification as a Tool for Treating Diabetic Foot Ulcers: Our Observations at a Suburban Teaching Hospital. Cureus. 2022;14(1):e21501. https://doi.org/10.7759/cureus.21501
McDermott K, Fang M, Boulton AJM, Selvin E, Hicks CW. Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care. 2023;46(1):209-221. https://doi.org/10.2337/dci22-0043
Armstrong DG, Tettelbach WH, Chang TJ, et al. Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018). J Wound Care. 2021;30(Sup7):S5-S16. https://doi.org/10.12968/jowc.2021.30.Sup7.S5
Tettelbach WH, Armstrong DG, Chang TJ, et al. Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment. J Wound Care. 2022;31(Sup2):S10-S31. https://doi.org/10.12968/jowc.2022.31.Sup2.S10
Zelen CM, Orgill DP, Serena TE, et al. Human Reticular Acellular Dermal Matrix in the Healing of Chronic Diabetic Foot Ulcerations that Failed Standard Conservative Treatment: A Retrospective Crossover Study. Wounds. 2017;29(2):39-45.
DiDomenico LA, Orgill DP, Galiano RD, et al. Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients. Int Wound J. 2018;15(6):950-957. https://doi.org/10.1111/iwj.12954
Serena T, Yaakov S, Yaakov R, King E, Driver VR. Percentage area reduction at week 4 as a prognostic indicator of complete healing in patients treated with standard of care: a post hoc analysis. J Wound Care. 2024;33(Sup9):S36-S42. https://doi.org/10.12968/jowc.2024.0141
Sheehan P, Jones P, Caselli A, Giurini JM, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Diabetes Care. 2003;26(6):1879-1882. https://doi.org/10.2337/diacare.26.6.1879
Kumar A, Naik BN, Ojha VS, et al. Factors associated with severity and outcomes of diabetic foot ulcers: A single center hospital-based cross-sectional observational study in Eastern India. J Family Med Prim Care. 2025;14(4):1431-1436. https://doi.org/10.4103/jfmpc.jfmpc_1703_24
Lee SH, Kim SH, Kim KB, Kim HS, Lee YK. Factors Influencing Wound Healing in Diabetic Foot Patients. Medicina (Kaunas). 2024;60(5):723. https://doi.org/10.3390/medicina60050723
Qin Q, Haba D, Nakagami G. Which biomarkers predict hard-to-heal diabetic foot ulcers? A scoping review. Drug Discov Ther. 2024;17(6):368-377. https://doi.org/10.5582/ddt.2023.01086
Lavery LA, Fulmer J, Shebetka KA, et al. The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. 2014;11(5):554-560. https://doi.org/10.1111/iwj.12329
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