Randomized Controlled Trial to Compare AmnioExcel Human Amniotic Allograft in Weekly Versus Biweekly Treatment of Diabetic Foot Ulcers.

Abstract

Our objective was to compare clinical outcomes in diabetic foot ulcers (DFU) treated with AmnioExcel^® applied weekly (AMX1) or biweekly (AMX2) over a 12-week evaluation period. This randomized clinical trial evaluated 40 people with UT 1A and 1D DFUs >30 days but less than 6 months duration and age >21 years. We excluded patients with untreated osteomyelitis, gangrene, widespread malignancy, or active substance abuse. Patients received amniotic tissue either once a week or every other week. We used a 3D measurement device (inSight, eKare, Fairfax, Virginia)". There was no difference in the incidence of healing (AMX1 30.0% vs AMX2 50.0%, p = 0.20), time to heal (69.3 ± 30.3 vs 45.8 ± 25.6 days, p = 0.15), or incidence of infection (AMX1 35.0% vs AMX2 25.0%, p = 0.49). The mean wound area reduction was 0.18 ± 0.48 cm² per week for AMX1 and 0.15 ± 0.63 cm² week for AMX2 (p = 0.42). When we compared wound healing trajectories in healers and non-healers. There were no differences in the mean wound area reduction for healers (0.26 ± 0.40 cm² per week) and non-healers (0.14 ± 0.52 cm² per week, p = 0.20). Our results suggested there is no difference in the incidence of healing, time to heal or incidence of infection based on weekly or biweekly application of amniotic tissue.