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

Razzaghi 2017.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled trial
Setting/location: Department of Infectious Disease, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran
Study duration: 12 weeks
Participants Sample size: n = 60 participants
Inclusion criteria:

  • grade 3 DFU according to Wagner‐Meggitt's criteria

  • aged 40–85 years


Exclusion criteria:

  • Pregnant and breastfeeding women

  • participants who consumed vitamin D supplements during the past 3 months,

  • anticipated changes in medications throughout the study

  • history of diseases that influence the development of DFU including chronic trauma


Participant characteristics:

  • men: 44 (73%); women: 16 (27%)

  • mean age: control: 58.6 ± 8.6; intervention: 59.6 ± 8.2

  • BMI: control: 26.2 ± 3.8; intervention: 26.0 ± 4.4

  • wound duration (weeks): not stated

  • baseline wound size (cm): not stated
Interventions Intervention:

  • 50,000 IU vitamin D supplements every 2 weeks for 12 weeks


Control:

  • placebo for 12 weeks
Outcomes Primary outcome

  • wound healing (reduction in wound length, breadth and width)
Notes Funded by a grant from the Vice Chancellor for Research, KUMS, and Iran
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote "Randomization assignment was performed using computer generated random numbers"
Allocation concealment (selection bias) Low risk Quote "Randomization and allocation were concealed from the researchers and participants until the final analyses were completed"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Vitamin D supplements and placebo capsules were similar in shape and size
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote "Randomization and allocation were concealed from the researchers and participants until the final analyses were completed"
Incomplete outcome data (attrition bias)
All outcomes Low risk All those randomised were analysed at end of study
Selective reporting (reporting bias) Low risk Study registered and all outcomes reported
Other bias Low risk None detected