Kralj 1996.

Methods	RCT (open design). Setting included both in‐patients and out‐patients in Slovenia.
Participants	40 patients recruited. Inclusion criteria: stasis leg ulcer, age < 86 years, complete mobility, written, informed consent. Exclusion criteria: ABPI < 0.8, systemic connective tissue disease, serological positive rheumatoid arthritis, severe concurrent diseases. Number of male:female patients: Group 1: 6:10; Group 2: 8:10. Mean (range) patient age in years: Group 1: 65 (40‐86); Group 2: 61 (36‐85). Mean (range) baseline ulcer area in cm2: Group 1: 18.6 (1‐57); Group 2: 17.2 (1‐47). Mean (range) duration of ulcers in months: Group 1: 7.9 (1‐24); Group 2: 6.9 (1‐36).
Interventions	Group 1: 4LB (Profore): wool, crepe, Litepress, Co‐Plus (n = 20 patients). Group 2: hydrocolloid dressing (Tegasorb) and single layer inelastic bandage (Porelast) (n = 20 patients). Bandages were changed at least weekly for all patients.
Outcomes	Number (%) patients with complete healing during 6‐month trial (NB patients started treatment at different points within this 6‐month period): Group 1: 7/20 (35%); Group 2: 8/20 (40%). Mean (range) days to healing: Group 1: 57.6 ( 7‐106); Group 2: 84.9 (28‐180). Number (%) patients withdrawing from trial (reasons): Group 1: 4/20 (20%) (admitted to hospital with heart condition 1, no transport to clinic 1, unknown reason 2); Group 2: 2/20 (10%) (cerebrovascular apoplexy 1, unknown reason 1).
Notes	Maximum length and width of ulcer measured at each bandage change. Ulcer surface area calculated as follows: a33 x b x π/4 (where a = maximum length (cm) and b = maximum width (cm)). If patients had multiple ulcers, the total ulcerated area was studied. Study described as ongoing.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Communication with trialists confirmed that randomisation was by sealed envelope, but not clear if opaque or numbered. Method of sequence generation unclear.
Allocation concealment (selection bias)	Unclear risk	Communication with trialists confirmed that randomisation was by sealed envelope, but not clear if opaque or numbered.
Incomplete outcome data (attrition bias) All outcomes	High risk	40 patients recruited; 4 people withdrew from Group 1 and 2 from Group 2: These people were not included in the analysis.
Blinded outcome assessment (healing)	Unclear risk	"Wounds were assessed by authors . . . " (personal correspondence).
Baseline comparability	Unclear risk	Mean ulcer areas and durations similar, but not very informative, since data skewed.