Tettelbach W, Cazzell S, Sigal F, Caporusso JM, Agnew PS, Hanft J, Dove C, et al.
International wound journal. Date of publication 2018 Sep 24;volume ():.
1. Int Wound J. 2018 Sep 24. doi: 10.1111/iwj.13001. [Epub ahead of print]
A multicentre prospective randomised controlled comparative parallel study of
dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic
foot ulcers.
Tettelbach W(1), Cazzell S(2), Sigal F(3), Caporusso JM(4), Agnew PS(5), Hanft
J(6), Dove C(7).
Author information:
(1)Wound Care & Hyperbaric Medicine Clinical Services, Intermountain Healthcare,
Salt Lake City, Utah.
(2)Limb Preservation Platform, Inc., Fresno, California.
(3)Foot and Ankle Clinic, Los Angeles, California.
(4)Futuro Clinical Trials, McAllen, Texas.
(5)Coastal Podiatry, Inc, Virginia Beach, Virginia.
(6)Miami Foot and Ankle, Miami, Florida.
(7)Advanced Foot & Ankle Center, Las Vegas, Nevada.
The aim of this study was to determine the safety and effectiveness of dehydrated
human umbilical cord allograft (EpiCord) compared with alginate wound dressings
for the treatment of chronic, non-healing diabetic foot ulcers (DFU). A
multicentre, randomised, controlled, clinical trial was conducted at 11 centres
in the United States. Individuals with a confirmed diagnosis of Type 1 or Type 2
diabetes presenting with a 1 to 15 cm2 ulcer located below the ankle that had
been persisting for at least 30 days were eligible for the 14-day study run-in
phase. After 14 days of weekly debridement, moist wound therapy, and off-loading,
those with ≤30% wound area reduction post-debridement (n = 155) were randomised
in a 2:1 ratio to receive a weekly application of EpiCord (n = 101) or
standardised therapy with alginate wound dressing, non-adherent silicone
dressing, absorbent non-adhesive hydropolymer secondary dressing, and gauze
bandage roll (n = 54). All wounds continued to have appropriate off-loading
during the treatment phase of the study. Study visits were conducted for
12 weeks. At each weekly visit, the DFU was cleaned and debrided as necessary,
with the wound photographed pre- and post-debridement and measured before the
application of treatment group-specific dressings. A follow-up visit was
performed at week 16. The primary study end point was the percentage of complete
closure of the study ulcer within 12 weeks, as assessed by Silhouette camera.
Data for randomised subjects meeting study inclusion criteria were included in an
intent-to-treat (ITT) analysis. Additional analysis was conducted on a group of
subjects (n = 134) who completed the study per protocol (PP) (EpiCord, n = 86,
alginate, n = 48) and for those subjects receiving adequate debridement (EpiCord,
n = 67, alginate, n = 40). ITT analysis showed that DFUs treated with EpiCord
were more likely to heal within 12 weeks than those receiving alginate dressings,
71 of 101 (70%) vs 26 of 54 (48%) for EpiCord and alginate dressings,
respectively, P = 0.0089. Healing rates at 12 weeks for subjects treated PP were
70 of 86 (81%) for EpiCord-treated and 26 of 48 (54%) for alginate-treated DFUs,
P = 0.0013. For those DFUs that received adequate debridement (n = 107, ITT
population), 64 of 67 (96%) of the EpiCord-treated ulcers healed completely
within 12 weeks, compared with 26 of 40 (65%) of adequately debrided
alginate-treated ulcers, P < 0.0001. Seventy-five subjects experienced at least
one adverse event, with a total of 160 adverse events recorded. There were no
adverse events related to either EpiCord or alginate dressings. These results
demonstrate the safety and efficacy of EpiCord as a treatment for non-healing
DFUs.
© 2018 The Authors. International Wound Journal published by Medicalhelplines.com
Inc and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.13001
PMID: 30246926
