Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)
Recruiting now · Not applicable
Conditions studied: Leg Ulcers
In brief
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
Key facts
- Study ID
- NCT06899919
- Run by
- Laboratoires URGO
- People needed
- 210
- Starts
- 2025-03-29
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2025-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON — Lyon, France (enrolling)
- Patricia SENET, Paris, Paris 75000 — Paris, Paris, France
- APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20 — Paris, France
Full record on ClinicalTrials.gov
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