Hanft JR, Surprenant MS, et al.
The Journal of foot and ankle surgery : official publication of the American College of Foot an.... Date of publication 2002 Sep 1;volume 41(5):291-9.
1. J Foot Ankle Surg. 2002 Sep-Oct;41(5):291-9.
Healing of chronic foot ulcers in diabetic patients treated with a human
fibroblast-derived dermis.
Hanft JR(1), Surprenant MS.
Author information:
(1)The Foot & Ankle Institute of South Florida, South Miami 33143, USA.
JRHSBRI@aol.com
A prospective, multicenter, randomized, controlled 12-week study was undertaken
to evaluate the effectiveness of a human fibroblast-derived dermis for treating
foot ulcers in the diabetic patient. This report summarizes the findings from one
center. Following a 2-week screening period, patients were randomized to either
human fibroblast-derived dermis (HFDD) (Dermagraft) plus saline-moistened gauze
or to the control group (CT) of saline-moistened gauze alone. Effectiveness end
points were: 1) wound closure by week 12, 2) time to wound closure, and 3)
percent wound closure by week 12. Safety was assessed by review of adverse events
and laboratory findings. Patients randomized to HFDD received an application at
day 0 and up to seven additional treatments. All patients in each group received
shoes with custom-molded inserts and were seen weekly. The study population was
comprised of 28 patients (14 HFDD/14 CT) with chronic ulcers (>6 weeks' duration
at time of screening). By week 12, significantly more chronic ulcers healed in
the HFDD group than in the CT group (71.4% versus 14.3%, p = .003). Healed HFDD
patients achieved wound closure significantly faster than CT patients (p = .004).
Patients treated with HFDD showed a statistically significant higher percent of
wound closure by week 12 than did CT patients (p = .002). The percent of patients
who experienced an infection involving their study wound was less in the HFDD
group than in the CT group. It was concluded that HFDD is a safe and effective
treatment for chronic foot ulcers in diabetic patients.
PMID: 12400712 [Indexed for MEDLINE]
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