ArticleJournal of vascular surgery. Venous and lymphatic disorders2026
Clinical outcomes and prognostic determinants of dehydrated human amnion/chorion membrane for refractory venous leg ulcers.
Article in Journal of vascular surgery. Venous and lymphatic disorders, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveThis study aimed to evaluate the effectiveness and safety of dehydrated human amnion/chorion membrane (dHACM) allograft for venous leg ulcers (VLUs) and to identify clinical factors associated with early healing within 12 weeks.
methodsThis single-center retrospective cohort study included 52 patients with CEAP C6 VLUs treated with dHACM at Shimokitazawa Hospital between February 2023 and June 2025. The primary outcomes were complete epithelialization and recurrence-free survival. Kaplan-Meier analysis was used to estimate healing rates. Early healing (within 12 weeks) was analyzed using univariate and multivariable Firth-penalized logistic regression, with directional consistency confirmed using univariate Cox proportional hazards analysis. Sensitivity analyses were performed by altering early-healing thresholds to 81 and 90 days. Variables with odds ratios (ORs) approximating 1.0 were further evaluated using predefined clinical equivalence margins (OR, 0.80-1.25). Adverse events were retrospectively assessed according to World Health Organization-Upsala Monitoring Centre criteria.
resultsAmong the 52 patients, 43 (82.7%) achieved complete healing, and the 12-week healing rate was 52.1%. Early healing occurred in 26 patients (50.0%). Multivariable analysis identified higher body mass index (adjusted OR, 0.847; 95% confidence interval, 0.739-0.948) and infection (adjusted OR, 0.253; 95% confidence interval, 0.060-0.913) as independent inhibitory factors, whereas independence in activities of daily living showed a tendency toward promoting healing. Cox analysis demonstrated consistent directional results. Sensitivity analyses using alternative thresholds (81 and 90 days) confirmed the robustness of key predictors. Ulcer area (OR, 0.999) and disease duration (OR, 1.002) were within the predefined equivalence margins, indicating minimal clinical impact. Recurrence occurred in six patients (14.0%), with recurrence-free survival rates of 90.5% at 1 year and 80.5% at 2 years. A total of 58 adverse events were observed in 33 patients (63.5%), most of which were mild and self-limiting; only two mild local reactions were considered possibly related to dHACM treatment.
conclusionsDespite being a descriptive study without a control group, favorable healing outcomes, low recurrence, and acceptable safety were observed in treatment-refractory venous leg ulcers managed with dHACM under Japan's stringent reimbursement criteria. Higher body mass index and infection were major predictors of delayed early healing, whereas ulcer area and disease duration had limited influence. These findings suggest that dHACM represents a valuable therapeutic option for patients with hard-to-heal VLUs.
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