Lee 2016.

Study characteristics
Methods	Research design: RCT, prospective, randomised, placebo‐controlled, single‐centre Care setting: not reported Country of origin: Korea Publication source:Wound Repair and Regeneration Year of publication: 2016 Duration of follow‐up: 12 weeks Sources of funding: Genewel (Seoul, South Korea) Unit of randomisation: participant Unit of analysis: participant Inclusion criteria: those with type 1 or 2 diabetes mellitus; aged over 20 years; those with an ulcer size ≥ 1 cm2 for more than 6 weeks, without signs of healing; those with an ulcer graded as Wagner stage 1 or 2; those with adequate circulation in the foot confirmed by transcutaneous partial pressure of oxygen (TcPO2) ≥ 30 mmHg or palpable pulses at the ankle (dorsalis pedis artery or posterior tibial artery); those with diabetic peripheral neuropathy diagnosed with the Michigan Neuropathy Screening Instrument (MNSI score of ≥ 2.5); those without local or systemic signs of DFU infection (local tenderness, erythema, fever, and leukocytosis); and those who signed the written consent form after full description of the clinical trial Exclusion criteria: diagnosis of presented osteomyelitis, systemic inflammatory disease, or autoimmune disease (e.g. rheumatoid arthritis, gout, systemic lupus erythematosus, and ankylosing spondylitis) and deep vein thrombosis; patients who were pregnant, were undergoing immunosuppressant treatment, or had any systemic wasting disease (e.g. chronic obstructive pulmonary disease, chronic heart failure, and malignancy)
Participants	Number of participants: 34 (ITT) participants were enrolled and randomised into the 2 groups with a 1:1 ratio (17 participants in each group). 25 (per‐protocol) participants were included in the final analysis (group 1: 13 participants; group 2: 12 participants). Male gender: group 1: 84% (n = 11); group 2: 66% (n = 8) Age: group 1: 57.08 ± 13.92; group 2: 57.58 ± 13.01
Interventions	Details of the intervention Group 1: hyaluronic acid dressing material (Healoderm, Genewel, Seoul, South Korea) Group 2: conventional moisture‐retentive dressing (sterile petrolatum gauze, SungKwang, Cheonan‐si, South Korea) Dressing procedure: thorough cleansing of the wound bed and margin with normal saline, additional debridement to remove necrotic tissues and expose healthy bleeding margin if necessary, trimming of the corresponding dressing material according to the size and shape of the ulcer, and direct application of the dressing material to the wound bed and then covering with polyurethane foam (Medifoam, Genewel). The dressing change was performed during the scheduled weekly follow‐up. However, depending on the amount of exudate, additional dressing change was performed 2 to 3 times per week. Both dressing materials were prepared in an identical packaging with the same label to ensure blinding. However, due to different morphology of the dressing materials, the investigators were not blind to the dressing materials. Co‐interventions: according to participants' clinical presentation (general strength, balance, gait pattern, and daily accommodation), an orthopaedic shoe with rigid sole, crutches, and/or wheelchairs were additionally prescribed Duration of treatment: 12 weeks
Outcomes	Primary outcomes of the review: complete wound healing (12 weeks); rate of adverse effects and events Secondary outcomes: change of wound size and area; velocity of healing was also reported
Notes	Losses to follow‐up: 9 participants (group 1: n = 4; group 2: n = 5)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A biostatistician who was blinded to the purpose of the study conducted a stratified permuted block randomizations using the SAS system"
Allocation concealment (selection bias)	Unclear risk	Authors do not describe how the allocation was concealed.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Both the dressing materials were prepared in an identical packaging with the same label to ensure blinding. However, due to different morphology of the dressing materials, the investigators were not blind to the dressing materials" Comments: there was no personnel blinding due to the characteristics of the dressing materials.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "... the ulcer size was measured by a trained orthopaedic fellow who was blind and independent of this study. The ulcer size was measured on a weekly basis, for 12 weeks, ..."
Incomplete outcome data (attrition bias) All outcomes	High risk	High number of participants lost in follow‐up, 9 out of 34 (26%). Authors did not use intention to treat analysis.
Selective reporting (reporting bias)	Low risk	All proposed outcomes described in methods section are presented and properly analysed.
Other bias	Low risk	The demographics, medical status, and baseline DFU characteristics of the 2 groups were similar. The authors declare that there are no conflicts of interest.