Veves Aristidis, Sheehan Peter, Pham Hau T
Joslin Beth Israel Deaconess Foot Center, One Deaconess Rd, Boston, MA 02215, USA.
Arch Surg. 2002 Jul;137(7):822-7. doi: 10.1001/archsurg.137.7.822.
Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers.
Randomized, prospective, controlled multicenter trial.
University teaching hospitals and primary care centers.
A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer.
Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks.
Complete healing of the study ulcer (wound).
After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P =.12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P =.056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P =.83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze.
Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration.
促愈生肌膜（一种由胶原蛋白和氧化再生纤维素组成的伤口敷料）在治疗慢性糖尿病足溃疡方面比标准护理更有效。
随机、前瞻性、对照多中心试验。
大学教学医院和初级保健中心。
来自11个中心的276名患者参与了该研究。患者的平均年龄为58.3岁（范围为23 - 85岁）。所有患者至少有1处糖尿病足溃疡。
患者被随机分为接受促愈生肌膜治疗组（n = 138）或湿纱布对照组（n = 138），并使用辅助敷料。根据临床需要更换敷料。每位患者的最长随访时间为12周。
研究溃疡（伤口）完全愈合。
治疗12周后，促愈生肌膜治疗组有51例（37.0%）患者伤口完全闭合，而对照组为39例（28.3%），但这种差异无统计学意义（P = 0.12）。在病程小于6个月的患者亚组中，治疗组之间的愈合差异达到临界显著性。在病程小于6个月的溃疡患者中，95例接受促愈生肌膜治疗的患者中有43例（45%）愈合，而89例对照组患者中有29例（33%）愈合（P = 0.056）。在病程至少6个月的伤口组中，对照组（10/49 [20%]）和促愈生肌膜组（8/43 [19%]；P = 0.83）愈合的患者数量相似。两组之间的安全性指标无差异。与湿纱布相比，患者和研究人员对促愈生肌膜表现出强烈的偏好。
在促进糖尿病足溃疡伤口愈合方面，促愈生肌膜与湿纱布相当。它对病程小于6个月的溃疡显示出额外的疗效，具有边缘统计学意义。此外，促愈生肌膜的安全性与湿纱布相似，且用户满意度更高。因此，促愈生肌膜可能是糖尿病足溃疡治疗中的一种有用辅助手段，特别是对于病程小于6个月的溃疡。
