Pilot trial of biovance collagen-based wound covering for diabetic ulcers.
BACKGROUND
Diabetes mellitus affects more than 194 million people worldwide, resulting in nearly 40,000 limb amputations per year, secondary to infected ulcerations, peripheral neuropathy, and inadequate vascular status. Diabetic foot ulcers have an underlying metabolic etiology that contributes to a nonhealing ulcer. Biovance (Celgene Cellular Therapeutics, Morris, New Jersey) is a wound covering produced from decellularized, dehydrated human amniotic membrane. The purpose of this study was to determine healing rates for partial- and full-thickness diabetic foot ulcers treated with Biovance. The secondary objective was to determine time to complete wound closure and safety profile.


METHODS
Open-label study of 14 patients with chronic nonhealing diabetic partial- or full-thickness ulcers.


RESULTS
Groups 1 and 2 (55.5% and 33.3%, respectively, comprising 60.1% of total participants) received a benefit from using Biovance wound covering, and there were no adverse reactions to the tissue.


CONCLUSIONS
Biovance helps decrease healing time for a population of patients with chronic nonhealing diabetic partial- or full-thickness foot ulcers. Randomized, controlled studies may be warranted.
Letendre
Serena
S
Cheshire Medical Center Dartmouth-Hitchcock Keene, Keene, New Hampshire, USA.
LaPorta
Guido
G
O'Donnell
Elaine
E
Dempsey
Jennifer
J
Leonard
Karen
K