Actively Recruiting
Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)
Led by Laboratoires URGO · Updated on 2025-04-08
210
Participants Needed
3
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Patricia SENET, Paris, Paris 75000
Paris, Paris, France, 75000
Not Yet Recruiting
2
Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON
Lyon, France, 69007
Actively Recruiting
3
APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20
Paris, France, 75970
Not Yet Recruiting
Research Team
A
Anne AnS SAUVADET, Dr, PhD
CONTACT
O
Olivier OlT TACCA, Dr, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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