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Study aim
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To determine and compare the effectiveness of vitamin D3 treatment regimen with a standard dose and a high dose on antioxidant markers in patients with diabetic foot ulcers.
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Design
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This is a phase 3 randomized, unblinded clinical trial on 50 patients, who will be randomly divided into 2 groups using block randomization.
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Settings and conduct
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Patients with diabetic foot ulcers at Imam Khomeini Hospital in Urmia will be assessed based on the severity of their wounds (Wagner classification). Weight and height, time of wound onset, number of wounds, previous hospitalization history for diabetic foot ulcers, and tobacco and alcohol consumption will be recorded. Tests for WBC, PLT, MPV, ESR, CRP, FBS, and HbA1c baseline, vitamin D levels, and MDA, NO, TAC levels will be requested.
Within 72 hours of hospitalization, one group will receive weekly treatment with 50,000 units of vitamin D pearls for three weeks, while the second group will receive a single intramuscular injection of 300,000 units of vitamin D. Three weeks after the intervention, the aforementioned tests will be checked routinely for the patients.
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Participants/Inclusion and exclusion criteria
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Entry criteria:
plasma calcium level less than 10
vitamin D level in between 20-30 ng/ml
age more than 18 years old
Diabetic foot ulcer grade 3 and 4 by wagner classification
plt count more than 100000 in the time of intramuscular injection
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Intervention groups
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Within 72 hours of hospitalization, one group will be treated with weekly vitamin D 50,000 pearl, with the first tablet provided to the patient upon admission and the remaining tablets consumed after one week. This process will continue for three weeks. The second group will receive a single dose of 300,000 units of intramuscular vitamin D.
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Main outcome variables
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Total Antioxidant Capacity; Malondialdehyde level; Nitric oxide level; Erythrocyte Sedimentation Rate; C-Reactive Protein