Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: A long-term follow-up study

Diabetic foot ulcers (DFU) are notoriously slow to heal and even in cases where primary healing is achieved ulcers frequently recur. An optimal treatment for DFU would be one that supports both rapid and long-term healing. Our purpose is to evaluate recurrence rates of DFU healed with use of dehydrated human amnion/chorion membrane (dHACM). Twenty-two patients with chronic DFU that healed with the use of dHACM were eligible for inclusion. All eligible patients had completed a single-center randomized clinical trial comparing rates of primary healing over a 12 week period with dHACM versus a standard regimen of care [20] (Zelen et al., 2013). Follow-up examinations were scheduled for 9-12 months after primary healing with dHACM. Subsequent evaluation of clinical records was made with IRB approval and patient consent. Eighteen of 22 eligible patients (81.8%) returned for follow-up examination. Mean wound size prior to treatment with dHACM was 3.1 ± 3.8 cm2, median 1.7 cm2 (0.7, 13.5). Mean time to wound closure after dHACM initiation was 3.1 ± 2.8 weeks (median 2.0 weeks, range 1.0-9.0 weeks). At the 9-12 month follow-up visit 17 of 18 (94.4%) wounds treated with dHACM remained fully healed. These findings support the effectiveness of dHACM for treatment of DFU.