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)
DOI:
https://doi.org/10.63676/3csvta73Keywords:
Cellular, acellular, and matrix-like products , Clinical trial protocol, Foot ulcer, diabetic, skin substitutesAbstract
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.
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