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

Razzaghi 2018.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled trial
Setting/location: Naghavi Hospital in Kashan, Iran
Date: December 2016‐February 2017
Study duration: 12 weeks
Participants Sample size: n = 70 participants
Inclusion criteria:
  • grade 3 DFU according to Wagner‐Meggitt's criteria

  • aged 40–85 years


Exclusion criteria:
  • pregnant and breast feeding

  • taking magnesium, multivitamin‐mineral and antioxidant supplements, and antiinflammatory agents

  • change in consuming medications throughout the study

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


Participant characteristics:
  • men: 24 (68.6%) (control), 22 (62.9%) (intervention); women: 11 (31.4%) (control), 13 (37.1%) (intervention)

  • mean age: control: 59.0 ± 10.1; intervention: 60.1 ± 11.1

  • BMI: control: 26.2 ± 4.1; intervention: 28.2 ± 5.2

  • wound duration (weeks): not stated

  • baseline wound size (cm):

    • control: 3.6 ± 1.6 (L); 2.9 ± 1.4 (W); 1.3 ± 0.6 (D);

    • intervention: 3.6 ± 2.7 (L); 3.3 ± 2.8 (W); 1.7 ± 1.1 (D)

Interventions Intervention:
  • 250 mg magnesium oxide supplements


Control:
  • placebo daily for 12 weeks

Outcomes Primary outcome
  • wound healing (reduction in wound length, breadth and width)

Notes The study was funded by a grant from the Vice Chancellor for Research, Kashan University of Medical Sciences
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomization assignment was conducted by 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 Quote: "allocation was concealed from the participants until the final analyses were completed"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "allocation was concealed from the researchers until the final analyses were completed"
Incomplete outcome data (attrition bias)
All outcomes Low risk All those randomised were analysed according to ITT
Selective reporting (reporting bias) Low risk Study registered and all outcomes reported
Other bias Low risk None detected