Blecken 2005.

Methods	RCT (within individual randomisation, no other details about method of randomisation). Trial conducted in USA, type of setting not described.
Participants	Recruited 12 patients with post‐thrombotic bilateral venous leg ulcers (7 men, 5 women). All had history of DVT. Inclusion criterion: ABPI ≥ 1.00. Exclusion criteria: chronic or acute systemic disease; and impaired mobility secondary to rheumatoid arthritis. Mean patient age 61 years; range 45‐82 (breakdown/group not reported). At baseline, patients had had active ulcers for 1‐6 years. Mean ± SE baseline ulcer area (cm2): Group 1: 48.98 ± 14.13; Group 2: 50.08 ± 18.30 (95% CI of difference Group 1 minus Group 2: ‐27.25‐25.07).
Interventions	All patients: prior to bandage application, ulcers cleansed with neutral soap and water and skin lubricated with lanolin. Compression reapplied every 72 h. Group 1: adjustable‐compression boot system consisting of: fine mesh paraffin‐impregnated gauze primary dressing (Aquafor); single layer of sterile absorbent gauze;1 cm‐thick felt pad cushion; surgical cotton stockinette; non‐elastic compression garment comprising a series of individually adjustable Velcro bands 5.1 cm wide extending from ankle to knee (CircAid); and elastic anklet (Medi) applied from base of toes to 5 cm above the malleolus (n = 12 limbs). Group 2: 4‐layer bandage (4LB) comprising: fine mesh paraffin‐impregnated gauze primary dressing (Aquafor); single layer of sterile absorbent gauze; 1 cm‐thick felt pad overlapping at least 3 cm of ulcer area; thick gauze bandage (Kerlix); and 15 cm wide elastic bandage (n = 12 limbs).
Outcomes	Number (%) limbs with complete healing at 12 weeks: Group 1: 4/12 (33%); Group 2: 4/12 (33%). Note: the same 4 individuals healed in each group. Mean ± SE ulcer area reduction rate (cm2 per week): Group 1: 2.93 ± 0.60; Group 2: 2.30 ± 0.70 (95% CI of difference Group 1 minus Group 2: 0.05‐1.21), P = 0.037 (paired t‐test). HR for area reduction rate: 0.56 (95% CI 0.33‐0.96), P = 0.017 (indicating faster healing rate in Group 1). The authors reported that patient age and sex were not associated with reduction rate, but statistics for covariates were not shown. Mean ± SE patient satisfaction score, assessed with scoring sheet at 12 weeks (1 = not satisfied; 2 = moderately satisfied; 3 = very satisfied): Group 1: 2.92 ± 0.08; Group 2: 2.58 ± 0.15 (95% CI of difference Group 1 minus Group 2: ‐0.08‐0.75), P = 0.104.
Notes	Ulcer area assessed at baseline then every 4 weeks by direct grid tracing combined with digital imaging. 4LB system was not the traditional one. No withdrawals. Skill of care provider not explained. HR for area reduction rate difficult to interpret as outcome variable was continuous rather than time‐to‐event.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"This was a randomised study . . .".
Allocation concealment (selection bias)	Unclear risk	No details provided.
Incomplete outcome data (attrition bias) All outcomes	Low risk	12 people recruited and all appear in results (individual patient data).
Blinded outcome assessment (healing)	Unclear risk	No details provided.
Baseline comparability	Unclear risk	Mean values reported for baseline ulcer area, and so difficult to judge comparability; no ulcer duration data presented.