Assessing the Outcomes and Complications of Skin Allografts in Healing Diabetic Foot and Venous Leg Ulcers: A Systematic Review of Randomised Controlled Trials.
Mathe C, Reddi S, et al. • International wound journal • 2026
Analysis of 19 randomised controlled trials demonstrated statistical significance in 12-week wound closure (p = 0.0394) for skin allografts treating chronic lower extremity wounds, with descriptive trends suggesting Theraskin, Epifix and Amnioband may offer greater clinical benefit, though no single graft demonstrated statistically superior outcomes.
Key Findings
Results
Skin allograft treatments showed statistically significant improvement in 12-week wound closure rates compared to standard care across 19 randomised controlled trials.
19 trials with a total of 1303 participants met inclusion criteria
Statistical significance was achieved for 12-week wound closure (p = 0.0394)
Searches were conducted in PubMed, Embase and Cochrane databases
Products compared included Apligraf, Theraskin, Amnioband, Amnioexcel, EpiCord and Epifix
Target wound types were chronic diabetic foot ulcers and venous leg ulcers
Results
Theraskin achieved the highest mean wound closure rate at 12 weeks among all allografts reviewed.
Theraskin achieved the highest mean closure rate of 84.7%
Amnioexcel achieved the lowest mean closure rate of 37.5%
No single graft demonstrated statistically superior outcomes compared to another
Descriptive trends suggest Theraskin may offer greater clinical benefit
Results
Epifix and Amnioband showed faster healing trends and greater closure advantages compared with standard care.
Primary outcomes assessed included complete wound closure at 12 weeks, time to healing, and percent area reduction
Both Epifix and Amnioband were identified alongside Theraskin as potentially offering greater clinical benefit based on descriptive trends
These findings are based on descriptive rather than statistically significant head-to-head comparisons
Results
Reported complications associated with skin allografts were uncommon and inconsistently defined across the reviewed trials.
Secondary outcomes assessed included infection, amputation and recurrence rates
Complication data were described as uncommon across the included trials
Inconsistent definitions of complications across trials limited comparative analysis
The inconsistency in complication reporting was identified as a methodological limitation
Background
Biologic skin allografts provide extracellular matrix components, cytokines, growth factors and viable cells derived from living or amniotic tissue that facilitate tissue repair in chronic wounds.
Chronic diabetic foot ulcers and venous leg ulcers were the target conditions due to delayed healing and high complication rates
Allografts reviewed were derived from either living or amniotic tissue sources
The mechanism of action involves delivery of extracellular matrix components, cytokines, growth factors and viable cells
Conclusions
The authors identified a need for large-scale head-to-head trials to establish the relative efficacy of different skin substitutes.
No head-to-head randomised controlled trials directly comparing the individual allografts to each other were identified
Current evidence is limited to comparisons of individual products against standard care
The findings are described as providing 'comparative insight to guide clinical selection of skin substitutes'
The review highlights the absence of definitive evidence establishing one product as superior to others
What This Means
This research systematically reviewed 19 clinical trials involving 1,303 patients to compare six different skin graft products — Apligraf, Theraskin, Amnioband, Amnioexcel, EpiCord, and Epifix — for treating two stubborn types of wounds: diabetic foot ulcers and venous leg ulcers. These wound types are notoriously difficult to heal because of underlying disease processes that impair the body's normal repair mechanisms. The skin graft products studied are derived from human living tissue or amniotic (placental) tissue and work by providing proteins, growth factors, and cells that help jump-start the healing process.
The analysis found that overall, these skin grafts were statistically significantly better than standard care at achieving complete wound closure by 12 weeks. Among the products studied, Theraskin had the highest average closure rate (84.7%), while Amnioexcel had the lowest (37.5%). Epifix and Amnioband also showed promising trends for faster healing. However, no single product was proven to be clearly better than all others in a statistically rigorous way. Complications such as infections and amputations were reported as uncommon, but the way complications were defined varied so much between studies that direct comparisons were difficult.
This research matters because chronic foot and leg wounds affect millions of people, particularly those with diabetes, and can lead to serious consequences including amputation. This review provides a useful summary to help clinicians choose among available skin graft options, but it also highlights a significant gap: no large studies have directly compared these products against each other. Such head-to-head trials would be needed before any one product can be confidently recommended over another.
Mathe C, Reddi S, Nahm W, Trikala A, Schwartz S. (2026). Assessing the Outcomes and Complications of Skin Allografts in Healing Diabetic Foot and Venous Leg Ulcers: A Systematic Review of Randomised Controlled Trials.. International wound journal. https://doi.org/10.1111/iwj.70892