Use of dermagraft, a cultured human dermis, to treat diabetic foot ulcers

• Published in: Diabetes care Vol. 19; no. 4; pp. 350 - 354
• Main Authors: GENTZKOW, G. D, IWASAKI, S. D, HERSHON, K. S, MENGEL, M, PRENDERGAST, J. J, RICOTTA, J. J, STEED, D. P, LIPKIN, S
• Format: Journal Article
• Language: English
• Published: Alexandria, VA American Diabetes Association 01-04-1996
• Subjects: Aged; Biological and medical sciences; Diabetes. Impaired glucose tolerance; Diabetic Foot - pathology; Diabetic Foot - physiopathology; Diabetic Foot - therapy; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Female; Humans; Male; Management. Various non-drug treatments. Langerhans islet grafts; Medical sciences; Occlusive Dressings; Patient Selection; Prospective Studies; Single-Blind Method; Skin; Wound Healing; Endocrinopathy; Human; Cell culture; Skin disease; Implant; Diabetes mellitus; Lower limb; Foot; Dressing; Association; Treatment; Complication; Ulcer; Biomaterial; Derm; Fibroblast; Growth factor
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/diacare.19.4.350

Use of dermagraft, a cultured human dermis, to treat diabetic foot ulcers.
G D Gentzkow ,
S D Iwasaki ,
K S Hershon ,
M Mengel ,
J J Prendergast ,
J J Ricotta ,
D P Steed and
S Lipkin
Advanced Tissue Sciences, Inc., La Jolla, CA 92037, USA.
Abstract
OBJECTIVE: To assess the effect of a tissue-engineered human dermis (Dermagraft) in healing diabetic foot ulcers. RESEARCH
DESIGN AND METHODS: This controlled prospective multicenter randomized single-blinded pilot study evaluated healing over a
12-week period in 50 patients with diabetic foot ulcers. These patients were randomized into four groups (three different
dosage regimens of Dermagraft and one control group). All patients received identical care except for the use of Dermagraft
tissue. Ulcer healing was assessed by percentage of wounds achieving complete or 50% closure, time to complete or 50% closure,
and volume and area measurements. RESULTS: Ulcers treated with the highest dosage of Dermagraft, one piece applied weekly
for 8 weeks (group A), healed significantly more often than those treated with conventional wound closure methods; 50% (6
of 12) of the Dermagraft-treated and 8% (1 of 13) of the control ulcers healed completely (P = 0.03). The percentage of wounds
achieving 50% closure was also significantly higher (75 vs. 23%; P = 0.018), and the time to complete or 50% closure was faster
(P = 0.056). The group A regimen was more effective than other treatment regimens. All three were better than the control,
however, and a dose-response was observed. There were no safety concerns. After a mean of 14 months of follow-up (range 11-22
months), there were no recurrences in the Dermagraft-healed ulcers. CONCLUSIONS: Dermagraft was associated with more complete
and rapid healing in diabetic foot ulcers. The recurrence data may indicate an improved quality of wound healing.