Status:
COMPLETED
High-Dose Vitamin D3 for Diabetic Foot Ulcer Healing: Randomized Controlled Trial
Lead Sponsor:
Universitas Sriwijaya
Conditions:
Diabetic Foot Ulcer
Vitamin D Deficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 com...
Detailed Description
Diabetic foot ulcers are a prevalent and serious complication of uncontrolled diabetes, with a significant proportion leading to infection, amputation, and mortality. Delayed wound healing in DFUs is ...
Eligibility Criteria
Inclusion
- Diagnosis of diabetic foot ulcer (DFU) Serum 25-hydroxyvitamin D level \< 30 ng/mL Willingness and ability to provide written informed consent Ability to comply with study procedures and follow-up visits
Exclusion
- Currently undergoing cancer treatment Pregnant or breastfeeding Current use of vitamin D supplementation History of autoimmune disease Chronic kidney disease with estimated GFR \< 30 mL/min/1.73 m² Abnormal liver function tests (AST or ALT ≥ 3× upper normal limit) Ankle-brachial index (ABI) \< 0.4 Presence of osteomyelitis Proven sepsis Allergy to vitamin D3 Amputation prior to randomization Withdrawal of consent during the study
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07139964
Start Date
July 1 2024
End Date
July 31 2025
Last Update
August 24 2025
Active Locations (1)
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1
Dr. Mohammad Hoesin General Hospital
Palembang, South Sumatra, Indonesia