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

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.