Topical Administration of on Diabetic Foot Ulcers Accelerates Healing: A Placebo-Controlled Randomized Clinical Study.

Hasan Fallah Huseini, Maryam Yaghoobi, Farhad Fallahi, Farzaneh Boroumand, Mohammad Hassan Ezzati, Seyyed Mohammad Tabatabaei, Homa Sotvan, Maryam Ahvazi, Shapour Badiee Aval, Mojtaba Ziaee

Journal: The international journal of lower extremity wounds 2024;23(2):238-246

PMID: 34719966

Abstract

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.

Address: Medicinal Plants Research Center, Institute of Medicinal Plants , ACECR, Karaj, Iran.; Department of Epidemiology, Iran University of Medical Sciences, Tehran, Iran.; Clinical Research Development Unit, Imam Reza Hospital, University of Medical Sciences, Mashhad, Iran.; Diabetic Clinic, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.; Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.; Mashhad University of Medical Sciences, Mashhad, Iran.; Medical Informatics Department, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.; Department of Complementary and Chinese Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.; Medicinal Plants Research Center, Maragheh University of Medical Sciences, Maragheh, Iran.
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