基于HYAFF 11的自体真皮和表皮移植治疗未感染的糖尿病足底和足背溃疡：一项前瞻性、多中心、对照、随机临床试验。

HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers: a prospective, multicenter, controlled, randomized clinical trial.

作者信息

Caravaggi Carlo, De Giglio Roberto, Pritelli Chiara, Sommaria Manuela, Dalla Noce Sergio, Faglia Ezio, Mantero Manuela, Clerici Giacomo, Fratino Pietro, Dalla Paola Luca, Mariani Giulio, Mingardi Roberto, Morabito Alberto

机构信息

Centre for the Study and Treatment of Diabetic Foot Pathology, Ospedale di Abbiategrasso, Milan, Italy.

出版信息

Diabetes Care. 2003 Oct;26(10):2853-9. doi: 10.2337/diacare.26.10.2853.

DOI:10.2337/diacare.26.10.2853

PMID:14514591

Abstract

OBJECTIVE

To evaluate the clinical efficacy and safety of HYAFF 11-based autologous dermal and epidermal grafts in the management of diabetic foot ulcers.

RESEARCH DESIGN AND METHODS

A total of 79 patients with diabetic dorsal (n = 37) or plantar (n = 42) ulcers were randomized to either the control group with nonadherent paraffin gauze (n = 36) or the treatment group with autologous tissue-engineered grafts (n = 43). Weekly assessment, aggressive debridement, wound infection control, and adequate pressure relief (fiberglass off-loading cast for plantar ulcers) were provided in both groups. Complete wound healing was assessed within 11 weeks. Safety was monitored by adverse events.

RESULTS

Complete ulcer healing was achieved in 65.3% of the treatment group and 49.6% of the control group (P = 0.191). The Kaplan-Meier mean time to closure was 57 and 77 days, respectively, for the treatment versus control groups. Plantar foot ulcer healing was 55% and 50% in the treatment and control groups, respectively. Dorsal foot ulcer healing was significantly different, with 67% in the treatment group and 31% in the control group (P = 0.049). The mean healing time in the dorsal treatment group was 63 days, and the odds ratio for dorsal ulcer healing compared with the control group was 4.44 (P = 0.037). Adverse events were equally distributed between the two groups, and none were related to the treatments.

CONCLUSIONS

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing. For plantar ulcers, the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment. This treatment, however, may be useful in patients for whom the total off-loading cast is not recommended and only a less effective off-loading device can be applied.

摘要

目的

评估基于HYAFF 11的自体真皮和表皮移植物治疗糖尿病足溃疡的临床疗效和安全性。

研究设计与方法

总共79例患有糖尿病足背（n = 37）或足底（n = 42）溃疡的患者被随机分为使用非粘性石蜡纱布的对照组（n = 36）或使用自体组织工程移植物的治疗组（n = 43）。两组均进行每周评估、积极清创、伤口感染控制以及适当的减压措施（足底溃疡使用玻璃纤维减压支具）。在11周内评估伤口完全愈合情况。通过不良事件监测安全性。

结果

治疗组65.3%的患者实现溃疡完全愈合，对照组为49.6%（P = 0.191）。治疗组和对照组的Kaplan-Meier平均愈合时间分别为57天和77天。足底溃疡在治疗组和对照组的愈合率分别为55%和50%。足背溃疡愈合情况有显著差异，治疗组为67%，对照组为31%（P = 0.049）。足背治疗组的平均愈合时间为63天，与对照组相比，足背溃疡愈合的优势比为4.44（P = 0.037）。不良事件在两组中分布均匀，且均与治疗无关。