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. 2020 Jul 17;2020(7):CD011378. doi: 10.1002/14651858.CD011378.pub2

Mozaffari‐Khosravi 2017.

Study characteristics
Methods Study design: RCT
Setting/location: Diabetic center of Hamadan University of Medical Sciences
Study duration: 4 weeks
Participants Sample size: n = 47 participants
Inclusion criteria:

  • DFU Wagner ≤ grade 2


Exclusion criteria:

  • pregnancy

  • autoimmune disease

  • taking anticonvulsants and antibiotics

  • osteomyelitis

  • renal insufficiency

  • hypertension

  • cutaneous tumours

  • venous ulcers or lymphedema

  • ulcer infection

  • lower limb paraesthesia

  • surgical debridement requirement


Participant characteristics:

  • Group A: 150,000 IU (n = 23)

    • age: 56.52 ± 7.61

    • men: 14 (60.9%); women: 9 (39.1%)

    • BMI: normal (18.5‐24.9) n = 5 (21.7%); overweight (25‐29.9) n = 16 (69.6%); obese (> 30) n = 2 (8.3%)

    • ulcer type: Wagner grade 1: n = 6 (26.1%); Wagner grade 2: n = 17 (73.9%)

    • ulcer area: 8.2 ± 1.38 cm

  • Group B: 300,000 IU (n = 24)

    • age: 57.46 ± 8.68

    • men: 13 (54.2%); women:11 (45.8%)

    • BMI: normal (18.5‐24.9) n = 10 (41.7%); overweight (25‐29.9) n = 12 (50%); obese (> 30) n = 2 (8.7%)

    • ulcer type: Wagner grade 1: n = 4 (16.7%): Wagner 2: n = 20 (83.3%)

    • ulcer area: 7.92 ± 1.9 cm
Interventions Group A received 150,000 IU of vitamin D through intramuscular injection
Group B received 300,000 IU of vitamin D through intramuscular injection
Outcomes Primary outcome
Wound healing: wound area reduction
Notes No funding declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the patients were randomly divided into two groups A and B according to the table of random numbers".
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not stated
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias)
All outcomes High risk 1 participant excluded in group A and 2 participants excluded in group B
Selective reporting (reporting bias) Low risk Study registered and all outcomes reported
Other bias Low risk None detected