Impact of Cilostazol versus Cilostazol and Selenium Combination on The Healing of Diabetic Foot Ulcer Patients: A Randomized Controlled Trial

BACKGROUND: Diabetic foot ulcer (DFU) is a debilitating complication of diabetes mellitus (DM). This study aimed to compare the impact of cilostazol alone or with selenium on wound healing in non-ischemic DFU patients. METHODS: A randomized controlled trial was conducted on 69 DFU patients. Eligible DFU patients were randomized to; Group1 (n = 23), received standard care only; Group2 (n = 23) received cilostazol plus standard care, Group3 (n = 23) received cilostazol/ selenium, plus standard care, all for 3 months. The Kruskal–Wallis and chi-squared tests were used for comparison among groups. RESULTS: After 3 months, as compared to controls, cilostazol alone or combined with selenium significantly reduced ulcer size parameters (length, width and depth) with p = 0.038, 0.000 and 0.001 respectively. The mean ulcer length, width, and depth in Group1 was reduced by (-1.46 cm, -0.184 cm, and -0.261 cm) respectively. Group2 showed reduction by (-2.704 cm, -1.90 cm and -0.608 cm) respectively and Group3 were reduced by (-3.630 cm, -2.24 cm and -0.50 cm) respectively. There was a complete response to treatment in 30% of group1, 65% of group2, and 43% of group3. CONCLUSION: Cilostazol addition to standard wound care significantly improved DFU healing. Addition of selenium to cilostazol had an added benefit to DFU healing on ulcer length and HMMP-9 serum levels. TRIAL REGISTRATION: Clinicaltrials.gov registry (NCT06117436), retrospectively registered on October 19th, 2023.