Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers - A prospective randomized multicenter clinical trial
A. Veves et al., Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers - A prospective randomized multicenter clinical trial, DIABET CARE, 24(2), 2001, pp. 290-295
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 r
andomly 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 a
dequate foot off-loading, was provided in both groups. Graftskin was applie
d at the beginning of the study and weekly thereafter for a maximum of 4 we
eks (maximum of five applications) or earlier if complete healing occurred.
The major outcome of complete wound healing was assessed by intention to t
reat at the 12-week follow-up visit.
RESULTS- At the 12-week follow-up visit, 63 (56%) Graftskin-treated patient
s achieved complete wound healing compared with 36 (38%) in the control gro
up (P = 0.0042). The Kaplan-Meier median time to complete closure was 65 da
ys for Graftskin, significantly lower than the 90 days observed in the cont
rol 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 bem een the two groups wit
h 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 availabl
e treatment and is not associated with any significant side effects. Grafts
kin may be a very useful adjunct for the management of diabetic foot ulcers
that are resistant to the currently available standard of care.