Veves A, Falanga V, Armstrong DG, Sabolinski ML, Apligraf Diabetic Foot Ulcer Study., et al.
Diabetes care. Date of publication 2001 Feb 1;volume 24(2):290-5.
1. Diabetes Care. 2001 Feb;24(2):290-5.
Graftskin, a human skin equivalent, is effective in the management of noninfected
neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical
trial.
Veves A(1), Falanga V, Armstrong DG, Sabolinski ML; Apligraf Diabetic Foot Ulcer
Study.
Author information:
(1)Joslin-Beth Israel Deaconess Foot Center and Harvard Medical School, Boston,
Massachusetts 02215, USA. aveves@caregroup.harvard.edu
OBJECTIVE: We assessed in a randomized prospective trial the effectiveness of
Graftskin, a living skin equivalent, in treating noninfected nonischemic chronic
plantar diabetic foot ulcers.
RESEARCH DESIGN AND METHODS: In 24 centers in the U.S., 208 patients were
randomly assigned to ulcer treatment either with Graftskin (112 patients) or
saline-moistened gauze (96 patients, control group). Standard state-of-the-art
adjunctive therapy, which included extensive surgical debridement and adequate
foot off-loading, was provided in both groups. Graftskin was applied at the
beginning of the study and weekly thereafter for a maximum of 4 weeks (maximum of
five applications) or earlier if complete healing occurred. The major outcome of
complete wound healing was assessed by intention to treat at the 12-week
follow-up visit.
RESULTS: At the 12-week follow-up visit, 63 (56%) Graftskin-treated patients
achieved complete wound healing compared with 36 (38%) in the control group (P =
0.0042). The Kaplan-Meier median time to complete closure was 65 days for
Graftskin, significantly lower than the 90 days observed in the control group (P
= 0.0026). The odds ratio for complete healing for a Graftskin-treated ulcer
compared with a control-treated ulcer was 2.14 (95% CI 1.23-3.74). The rate of
adverse reactions was similar between the two groups with the exception of
osteomyelitis and lower-limb amputations, both of which were less frequent in the
Graftskin group.
CONCLUSIONS: Application of Graftskin for a maximum of 4 weeks results in a
higher healing rate when compared with state-of-the-art currently available
treatment and is not associated with any significant side effects. Graftskin may
be a very useful adjunct for the management of diabetic foot ulcers that are
resistant to the currently available standard of care.
PMID: 11213881 [Indexed for MEDLINE]
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