USE OF DERMAGRAFT, A CULTURED HUMAN DERMIS, TO TREAT DIABETIC ROOT ULCERS

OBJECTIVE - To assess the effect of a tissue-engineered human dermis ( Dermagraft) in healing diabetic foot ulcers. RESEARCH DESIGN AND METHO DS - This controlled prospective multicenter randomized single-blinded pilot study evaluated healing over a 12-week period in 50 patients wi th diabetic foot ulcers. These patients were randomized into lour grou ps (three different dosage regimens of Dermagraft and one control grou p). All patients received identical care except for the use of Dermagr aft tissue. Ulcer healing was assessed by percentage of wounds achievi ng complete or 50% closure, time to complete or 50% closure, and volum e and area measurements. RESULTS - Ulcers treated with the highest dos age of Dermagraft, one piece applied weekly for 8 weeks (group A), hea led significantly more often than those treated with conventional woun d closure methods; 50% (6 of 12) of the Dermagraft-treated and 8% (1 o f 13) of the control ulcers healed completely (P = 0.03), The percenta ge of wounds achieving 50% closure was also significantly higher (75 v s. 23%; P = 0.018), and the time to complete or 50% closure was faster (P = 0.056). The group A regimen nas more effective than other treatm ent regimens. All three were better than the control, however, and a d ose-response was observed. There were no safety concerns. After a mean of 14 months of follow-up (range 11-22 months), there were no recurre nces in the Dermagraft-healed ulcers. CONCLUSIONS - Dermagraft was ass ociated with more complete and rapid healing in diabetic foot ulcers. The recurrence data may indicate an improved quality of wound healing.