High-Dose Vitamin D3 for Diabetic Foot Ulcer Healing: Randomized Controlled Trial
High-Dose Vitamin D3 for Diabetic Foot Ulcer Healing: Randomized Controlled Trial
NCT ID: NCT07139964 Phase: NA Status: COMPLETED Enrollment: 24 Completion: 2025-07-31
Conditions
Diabetic Foot Ulcer, Vitamin D Deficiency, Wound Healing Disorder
Interventions
Vitamin D3, Placebo
Summary
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of high-dose vitamin D3 supplementation in improving diabetic foot ulcer (DFU) healing. DFUs are common, serious complications of diabetes, often associated with delayed wound healing due to persistent inflammation, impaired angiogenesis, and imbalances between matrix metalloproteinase-9 (MMP-9) and its tissue inhibitor (TIMP-1). Vitamin D deficiency is prevalent among DFU patients and is linked to impaired fibroblast function, poor angiogenesis, and increased inflammation.
Participants with DFUs and serum vitamin D levels \<30 ng/mL will be randomized to receive either 10,000 IU oral vitamin D3 daily or placebo for 28 days, in addition to standard DFU care. Primary outcomes include changes in tissue MMP-9/TIMP-1 expression ratio and wound healing progression. The study will provide evidence on whether high-dose vitamin D3 can serve as a safe, effective adjunctive therapy in DFU management.
Primary Outcome
Change in tissue MMP-9/TIMP-1 expression ratio from baseline to Day 28