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Clinical superiority of an innovative two-component compression system versus four-component compression system in treatment of active venous leg ulcers: a randomized trial
Gillet JL, Guex JJ, Allaert FA, Avouac B, Leger P, Blaise S, Marchand A, Maillard H, Simon M, Amor CB, Pasqualini M
Phlebology 2019 Oct;34(9):611-620
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate the efficacy, safety and acceptability of an innovative two-component versus a well-established four-component compression systems in the management of venous leg ulcer. METHOD: Multicentre randomized controlled trial in patients with active venous leg ulcer. Patients were followed-up monthly for a maximum of 16 weeks. The primary endpoint was the complete healing rate at 16 weeks. RESULTS: Ninety-two patients were randomized to either the two-component BIFLEX Kit group (n = 49) or the four-component PROFORE group (n = 43). In the full analysis set (n = 88), a complete healing rate of 48.9% and 24.4% was reported in BIFLEX Kit versus PROFORE groups, respectively (ie, a superiority of 24.5%, p = 0.02). Acceptability of BIFLEX Kit was higher from both the patients' and physicians' perspectives. CONCLUSION: The BIFLEX Kit represents a valid alternative therapy in the management of venous leg ulcer according to its clinical efficacy, safety and acceptability with potential positive impacts on healthcare costs.

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