A Multicenter, Prospective, Randomized, Controlled, Comparative, Parallel Study of Dehydrated Human Umbilical Cord Allograft for the Treatment of Diabetic Foot UlcersWilliam Tettelbach, MD; Shawn Cazzell, DPM; Felix Sigal, DPM; Joseph M. Caporusso, DPM; Patrick Agnew, DPM; Jason Hanft, DPM; and Cyaandi Dove, DPM
OBJECTIVE: To determine the safety and effectiveness of dehydrated human umbilical cord allograft for the treatment of chronic, nonhealing diabetic foot ulcers (DFUs).
MATERIALS AND METHODS: An institutional review board-approved, multicenter, randomized controlled trial was conducted at 11 centers in the United States. Individuals with diabetes and a DFU measuring 1 cm2 to 15 cm2 below the ankle for at least 30 days were eligible for the 14-day run-in phase with weekly debridement, moist wound therapy, and offloading. Those with > 30% wound area reduction postdebridement were randomized in a 2:1 ratio to receive a weekly application of allograft (n = 101) or standardized therapy with alginate wound dressing, nonadherent silicone dressing, absorbent nonadhesive hydropolymer secondary dressing, and gauze (n = 54). All DFUs were appropriately offloaded. Study visits with debridement, wound photography, measurement, and treatment-group specific dressings were conducted for 12 weeks. The primary outcome was percent of DFUs with complete closure within 12 weeks. Data were evaluated using an intent-to-treat (ITT) analysis (n = 155). Additional analysis was conducted on patients completing the study per protocol (PP) (n = 134; allograft, n = 86; alginate, n = 48) and for those patients receiving adequate debridement (allograft, n = 67; alginate, n=40).
RESULTS: The ITT analysis showed DFUs treated with the allograft had higher healing rates within 12 weeks than those receiving alginate dressings, 71 of 101 (70%) versus 26 of 54 (48%) for allograft and alginate dressings, respectively (P = .0089). The PP healing rates at 12 weeks were 70 of 86 (81%) for allograft-treated and 26 of 48 (54%) for alginate-treated DFUs (P = .0013). For those DFUs with adequate debridement (n = 107, ITT population), 64 of 67 (96%) of the allograft-treated ulcers healed completely within 12 weeks compared with 26 of 40 (65%) of alginate-treated ulcers (P < .001). One-hundred and sixty adverse events were reported from 75 patients. None were related to either allograft or alginate dressings.
CONCLUSIONS: These results demonstrate the importance of adequate wound debridement and the safety and efficacy of dehydrated human umbilical cord allograft as a treatment for nonhealing DFUs.
Tettelbach W, Cazzell S, Sigal F, et al. A multicenter, prospective, randomized controlled, comparative, parallel study of dehydrated human umbilical cord allograft for the treatment of diabetic foot ulcers. Poster presented at: Symposium on Advanced Wound Care Fall; November 2-4, 2018; Las Vegas, NV.
Product: EpiCord (MiMedx, Inc, Marietta, GA)
This abstract was not subject to the WOUNDS peer-review process.