Medicinal Plants Research Center, Institute of Medicinal Plants , ACECR, Karaj, Iran.
Department of Epidemiology, Iran University of Medical Sciences, Tehran, Iran.
Int J Low Extrem Wounds. 2024 Jun;23(2):238-246. doi: 10.1177/15347346211048371. Epub 2021 Nov 1.
Diabetic foot ulcer is one of the most devastating complications of uncontrolled diabetes. Although there have been advances in the management of diabetic foot ulcers, still diabetic foot ulcers are a major cause of many amputations in diabetic patients. () is widely used by folk medicine practitioners in Iran for the treatment of diabetic ulcers.The present study was designed to evaluate the safety and efficacy of topical ointment besides the standard treatment in diabetic foot ulcers.A total of 70 diabetic patients with foot ulcers grade 1 or 2 according to Wagner's scale were enrolled in this study. Patients were randomly divided into two groups. Patients in both groups received standard treatment for diabetic foot ulcers. In addition, group 1 received topical ointment, and group 2 received topical placebo ointment for 4 weeks. The and placebo ointments were rubbed twice daily two hours before the conventional dressing. The ulcer size, healing time, and laboratory tests were measured in both groups at baseline and end of the study after 4 weeks.Twenty-nine patients remained in the group and 26 in the placebo group until the end of the study. The mean surface area of ulcers was 3.52 ± 1.47 and 3.21 ± 1.67 cm in group and placebo group respectively at baseline which decrease to .717 ± .19 and 1.63 ± .72 cm respectively at the endpoint. The mean ulcer surface area was significantly lower in compared with the placebo group ( < .0001) at end of the study. Also, the number of patients that completely recovered in the group was significantly higher than the placebo group ( < .001) at the end of the study.The addition of topical ointment to standard treatment significantly improves the healing time of diabetic non-infected foot ulcers.
糖尿病足溃疡是糖尿病未得到控制的最严重的并发症之一。尽管在糖尿病足溃疡的治疗方面已经取得了进展,但糖尿病足溃疡仍然是导致许多糖尿病患者截肢的主要原因。()在伊朗民间医学从业者中被广泛用于治疗糖尿病溃疡。本研究旨在评估局部 软膏除标准治疗外对糖尿病足溃疡的安全性和疗效。
共有 70 名根据 Wagner 量表处于 1 或 2 级的糖尿病足溃疡患者纳入本研究。患者随机分为两组。两组患者均接受糖尿病足溃疡的标准治疗。此外,第 1 组接受局部 软膏治疗,第 2 组接受局部安慰剂软膏治疗,持续 4 周。在常规敷料前两小时,每日两次涂抹 软膏和安慰剂软膏。在基线和 4 周研究结束时,测量两组的溃疡大小、愈合时间和实验室检查结果。
在研究结束时,29 名患者留在 组,26 名患者留在安慰剂组。在基线时, 组和安慰剂组的溃疡平均表面积分别为 3.52 ± 1.47 和 3.21 ± 1.67 cm,在终点时分别减少至.717 ±.19 和 1.63 ±.72 cm。在研究结束时, 组的平均溃疡表面积明显低于安慰剂组(<.0001)。此外,在研究结束时,完全康复的患者在 组中的数量明显高于安慰剂组(<.001)。
局部应用 软膏联合标准治疗可显著缩短糖尿病非感染性足部溃疡的愈合时间。