IRCT20220928056051N4
Not yet recruiting
Phase 3
Comparing the high dose and conventional regimen of vitamin D effect on paraclinical factors affecting the healing of diabetic foot ulcer
Oroumia University of Medical Sciences0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diabetic foot ulcer.
- Sponsor
- Oroumia University of Medical Sciences
- Enrollment
- 60
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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