Investigating the effect of vitamin D in the treatment of diabetic foot ulcers

Phase 3

Conditions: Diabetic foot ulcer.
Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy
E08.610

Registration Number: IRCT20220928056051N4

Lead Sponsor: Oroumia University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients with vitamin D levels between 10-30 ng/dL
Age over 18 years
Diabetic foot ulcer grade 3 and 4 according to Wegener criteria
Plasma calcium below 10
Platelet count above 100,000

Exclusion Criteria

Allergy to vitamin D products
Known diseases associated with hypercalcemia
Pregnancy and breastfeeding
Patients treated with chemotherapy or radiotherapy drugs
Taking drugs that interfere with wound healing, such as: corticosteroids, a minimum dose equivalent to 40 mg of prednisolone, mycophenolate, cyclosporine, tacrolimus, rituximab
Patients with severe renal failure, GFR<30 ml/min
Taking vitamin D supplements during the last month
Received injectable antibiotics for diabetic foot ulcer during the last month before hospitalization
Stenosis and severe clogging of vessels of the lower limbs based on vascular ultrasound
Chronic alcohol consumption of more than 250 cc daily

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Erythrocyte Sedimentation (ESR). Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;C-reactive protein (CRP). Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;Fasting blood sugar (FBS). Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;Glomerular filtration rate (GFR). Timepoint: Before and three weeks after the intervention. Method of measurement: Based on the formula.;Creatinine. Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;Alanine transaminase (ALT). Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;Aspartate transferase (AST). Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;Alkaline phosphatase (ALP). Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.

Secondary Outcome Measures