Use of Dermagraft, a Cultured Human Dermis, to Treat Diabetic Foot Ulcers
Use of Dermagraft, a Cultured Human Dermis, to Treat Diabetic Foot Ulcers
复制标题
使用 Dermagraft（一种培养的人类真皮）治疗糖尿病足溃疡
作者：
G. Gentzkow;Scott D Iwasaki;K. Hershon;Marvin Mengel;J. Prendergast;J. Ricotta;D. P. Steed;Scott Lipkin
目的评价组织工程人真皮（Dermagraft）在糖尿病足溃疡愈合中的作用。研究设计和方法：本前瞻性对照多中心随机单盲先导研究评估了50例糖尿病足溃疡患者在12周内的愈合情况。这些患者被随机分为四组（三个不同剂量的Dermagraft方案和一个对照组）。除了使用真皮组织外，所有患者都接受了相同的护理。通过伤口完全或50%愈合的百分比、完全或50%愈合的时间以及体积和面积测量来评估溃疡愈合。结果使用最高剂量Dermagraft（每周一片，连用8周）治疗的溃疡愈合率明显高于常规伤口闭合方法治疗的溃疡；50%（6 / 12）的皮肤组溃疡完全愈合，8%（1 / 13）的对照组溃疡完全愈合（P = 0.03）。创面愈合50%的比例也显著高于对照组（75% vs. 23%; P = 0.018），愈合50%的时间也更快（P = 0.056）。A组方案比其他治疗方案更有效。然而，这三种药物都比对照组好，并且观察到剂量反应。没有安全问题。经过平均14个月的随访（11-22个月），皮肤愈合的溃疡没有复发。结论：皮肤移植与糖尿病足溃疡更完全、更快的愈合有关。复发数据可能表明伤口愈合质量有所改善。
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.