Diabetes Research Unit, E. Wolfson Medical Center, Halohamim 62, Holon, Israel.
Diabetes Technol Ther. 2011 Dec;13(12):1255-60. doi: 10.1089/dia.2011.0018. Epub 2011 Jul 13.
Diabetic foot ulcers are associated with significant morbidity. Conventional treatment modalities are often of limited success in promoting complete wound closure. The aim of the present study was to examine the efficacy of noninvasive ozone-oxygen therapy in the treatment of diabetic foot ulcers.
Diabetes patients with a Wagner classification stage 2 or 3 ulcer or a stage 4 ulcer after debridement of at least 8 weeks in duration were included in this double-blind, randomized, placebo-controlled clinical trial. Patients received conventional treatment in combination with either ozone-oxygen treatment or sham treatments for 12 weeks, and after an additional 12 weeks, wound status was re-examined.
In total, 61 patients (62% male, 62.6±9.8 years old) participated in the study; 32 were randomized to ozone treatment, and 29 to placebo. The proportion of subjects with full wound closure did not differ significantly by treatment assignment (41% vs. 33%, P=0.34). Among the 34 subjects who completed the study per protocol (PP) (16 in the ozone group, 18 in the placebo group), a significantly higher rate of complete wound closure was observed in the ozone group (81% vs. 44%, P=0.03). Among PP patients with wound size ≤5 cm(2), the rate of total wound closure was 100% versus 50% in the sham treatment group (P=0.006). A nonsignificant, 55.5% relative increase in healed wound area was detected in the ozone group versus the placebo group (4.2±4.9 cm(2) vs. 2.7±1.5 cm(2), P=0.23).
Among PP patients, ozone treatment in addition to conventional treatment was superior to conventional treatment alone in promoting the complete healing of diabetic foot ulcers.
糖尿病足溃疡会导致严重的发病率。传统的治疗方法在促进完全愈合方面往往效果有限。本研究旨在检查非侵入性臭氧-氧气疗法治疗糖尿病足溃疡的疗效。
本双盲、随机、安慰剂对照临床试验纳入了 Wagner 分级 2 或 3 期溃疡或清创后至少 8 周的 4 期溃疡的糖尿病患者。患者接受常规治疗联合臭氧-氧气治疗或假治疗 12 周，然后在额外 12 周后重新检查伤口状况。
共有 61 名患者（62%为男性，62.6±9.8 岁）参与了这项研究；32 名患者随机分配到臭氧治疗组，29 名患者分配到安慰剂组。按治疗分配，完全愈合的患者比例无显著差异（41%比 33%，P=0.34）。在按方案完成研究的 34 名受试者中（臭氧组 16 名，安慰剂组 18 名），臭氧组完全愈合的比例显著更高（81%比 44%，P=0.03）。在伤口面积≤5 cm²的按方案患者中，臭氧组的总愈合率为 100%，而假治疗组为 50%（P=0.006）。臭氧组与安慰剂组相比，愈合伤口面积增加了 55.5%（臭氧组 4.2±4.9 cm²，安慰剂组 2.7±1.5 cm²，P=0.23）。
在按方案患者中，常规治疗联合臭氧治疗在促进糖尿病足溃疡完全愈合方面优于单独常规治疗。
