Clever 1995.

Methods	Two‐arm RCT (not clear if single centre or multi‐centred) comparing a foam dressing (Allevyn, Smith & Nephew) with a hydrocolloid (polyurethane matrix) dressing (Cutinova Hydro, Smith & Nephew, previously Beiersdorf) undertaken in Germany. Duration of follow‐up: Until healing occurred or for a maximum of 16 weeks.
Participants	40 participants Inclusion criteria: Patients aged 18 to 80 years with a pure neuropathic superficial ulcer 1 to 5 cm in diameter and with no clinical and radiological signs of osteomyelitis or tendon involvement. Exclusion criteria: Patients an ABPI < 0.8 (measured using doppler ultrasound ) and with clinical or radiological signs of osteomyelitis or tendon involvement. Ulcers requiring topical treatment were also excluded, as were patients with know allergies to any product being used.
Interventions	Group A (n = 20): Foam dressing (Allevyn, Smith & Nephew). Group B (n = 20): Hydrocolloid (polyurethane matrix) dressing (Cutinova Hydro, Smith & Nephew). In both groups, dressing changes were performed as often as required but at least once a week. Co‐intervention: Pressure relief comprising a half‐shoe or so‐called 'heal sandal', therapeutic footwear with cushioned insoles, and crutches as required to meet individual needs, infection control with systemic antibiotics if required, wound cleansing with Ringer's solution and debridement with removal of callus if needed.
Outcomes	Primary outcome: Ulcer healing (number of ulcers healed; mean time to healing; median time to healing; wound size at 4 weeks mm2). Secondary outcomes: Adverse events; costs (mean number of dressing changes between clinical visits). Health‐related quality of life; amputations, ulcer recurrence not reported.
Notes	Trial data: Analysis 4.1 Source of funding: Beiersdorf AG, Hamburg.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote:"Conducted an open, randomised, controlled study". Comment: Method of generation of random schedule not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: The process of randomising participants, including who did this is not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Conducted an open, randomised, controlled study". Comment: This was labelled an open trial not clear if blinded evaluation was conducted.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote:"Conducted an open, randomised, controlled study". Comment: This was labelled an open trial not clear if blinded evaluation was conducted.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: In total six participants were withdrawn, or 15% of the total study population. The study report states that withdrawals were excluded from the analyses.
Selective reporting (reporting bias)	Low risk	Comment: Based on paper only, protocol not obtained.
Other bias	Unclear risk	Comment: Funded by commercial organisation.