Soleimani 2017.

Study characteristics
Methods	Study design: randomised, double‐blind, placebo‐controlled trial Setting/location: an infectious clinic affiliated to Kashan University of Medical Sciences (KUMS), Kashan, Iran Date: April 2016‐July 2016 Study duration: 12 weeks
Participants	Sample size: n = 60 participants Inclusion criteria: 3 DFU according to Wagner‐Meggitt's criteria aged 40–85 years deep ulcer with cellulitis normal distal pulse Exclusion criteria: pregnant and breastfeeding grade 3 DFU with abscess formation and osteomyelitis significant arterial disease, major deformities e.g. Charcot's neuroarthropathy taking antioxidant and/or anti‐inflammatory supplements such as vitamin E, vitamin C omega‐3 fatty acids and change in consuming medications throughout the study Participant characteristics: men: 46 (76.7%); women: 14 (23.3%) mean age: control: 59.9 ± 9.2; intervention: 58.8 ± 11.2 BMI: control: 26.9 ± 2.7; intervention 27.0 ± 4.5 wound duration (weeks): 3.4 ± 0.8 (control); 3.3 ± 0.9 (intervention) baseline wound size (cm): control: 3.4 ± 1.7 (L); 2.9 ± 1.3 (W); 1.3 ± 0.6 (D); intervention: 3.5 ± 2.3 (L); 2.9 ± 2.1 (W); 1.4 ± 0.5 (D)
Interventions	Intervention: 1000 mg/day omega‐3 fatty acid from flaxseed oil twice a day for 12 weeks Control: placebo twice a day 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

BMI: body mass index; CFU/g: colony‐forming unit, is a unit used to estimate the number of viable bacteria or fungal cells in a sample; D: depth; DFU: diabetic foot ulcer; EQ‐5D: EuroQoL‐5D; HbA1c: measurement of blood glucose; HMB: β‐hydroxy‐β‐methylbutyrate; HRQoL: health‐related quality of life; ITT: intention‐to‐treat; L: length; PEM: protein‐energy malnutrition; QoL: quality of life; RCT: randomised controlled trial; W: width