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

Comparing the high dose and conventional regimen of vitamin D effect on paraclinical factors affecting the healing of diabetic foot ulcer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220928056051N4
Enrollment
60
Registered
2024-05-18
Start date
2024-06-04
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot ulcer. Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy

Interventions

Intervention 1: Intervention group: In the first group, patients will be treated with vitamin D 50,000 units orally weekly for three weeks (conventional regimen).Tablets will be provided by Dana Phar

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
White blood count (WBC). Timepoint: Before and three weeks after the intervention. Method of measurement: Neobar slide (hemocytometer).;Mean platelet volume (MPV). Timepoint: Before and three weeks after the intervention. Method of measurement: Neobar slide (hemocytometer).;Platelet count. Timepoint: Before and three weeks after the intervention. Method of measurement: Neobar slide (hemocytometer).;Triglyceride (TG). Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;Cholesterol. Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;High-density lipoprotein (HDL). Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;Low-density lipoprotein (LDL). Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;Calcium. Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.;Ferritin. Timepoint: Before and three weeks after the intervention. Method of measurement: Biochemistry test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Laya Hooshmand

Oroumia University of Medical Sciences

hoshmand.l@umsu.ac.ir+98 44 3345 7286

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026