Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of a lite compression system versus a tubular bandage in the local treatment of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study
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Eligibility Criteria
Inclusion Criteria:
* Adult patient (≥ 18 years old), having given free, informed and written consent
* Patient affiliated to a social security scheme
* Patient agreeing to wear the study compression system daily
* Patient with an ankle circumference between 18 and 25 cm
* Target wound: stage C6 / …
Inclusion Criteria:
* Adult patient (≥ 18 years old), having given free, informed and written consent
* Patient affiliated to a social security scheme
* Patient agreeing to wear the study compression system daily
* Patient with an ankle circumference between 18 and 25 cm
* Target wound: stage C6 / C6r mixed leg ulcer of the CEAP classification with a 0.6≤ ABPI≤0.8 and TABP≥ 50 mm Hg and arterial echo Doppler confirming the mixed nature of the leg ulcer
* Target wound with an area between 2 and 20 cm2
* Target wound with age of ≤18 months
Criteria exclusion:
* Patient with a systemic infection not controlled by appropriate antibiotic therapy
* Patient having presented in the 3 months preceding his inclusion, a deep vein thrombosis
* Severe arterial pathology, including an Ankle Blood Pressure Index (ABPI) less than 3 months old \<0.6
* Patient bedridden or spending less than an hour per day standing
* Clinically infected target wound
* Cancerized target wound
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