Evaluating a light compression system for treating mixed leg ulcers
Official title: Evaluation of the Efficacy and Safety of Light Compression System Versus Tubular Bandage in the Local Treatment of Mixed Leg Ulcers: a Prospective Open-label RCT
Run by Laboratoires URGO · NCT06899919 · Data updated 2026-11-12
This study is testing a new light compression system to see if it helps adults with mixed leg ulcers heal better than a regular bandage.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Laboratoires URGO Industry-sponsored |
| Locations | 3 sites (Paris, Paris and 2 other locations) |
| Status | Recruiting |
| Started | March 29, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | April 8, 2025 |
| Trial ID | NCT06899919 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with stage C6 / C6r mixed leg ulcers that meet specific clinical criteria.
✕Probably not a fit
Patients with systemic infections, severe arterial pathology, or clinically infected wounds may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial assesses the efficacy and safety of a light compression system compared to a tubular bandage for the treatment of mixed leg ulcers. Conducted across approximately 50 centers in France, the study will enroll 210 adult patients with specific eligibility criteria related to their leg ulcers. Participants will undergo a series of evaluations over 16 weeks, including wound assessments and quality of life questionnaires, to determine the effectiveness of the treatment. The study aims to provide insights into wound healing and patient outcomes associated with the light compression system.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing times and quality of life for patients with mixed leg ulcers.
How similar studies have gone: Other studies have shown promising results with similar compression therapies, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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 / 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's running
-
Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON
Lyon, France Recruiting -
Patricia SENET, Paris, Paris 75000
Paris, Paris, France Not yet recruiting -
APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20
Paris, France Not yet recruiting
Study contacts
- Principal investigator: Patricia PaS SENET, Dr, MD, PhD — Hôpitaux Universitaires Paris Est (AP-HP) - Hôpital TENON
- Study coordinator: Anne AnS SAUVADET, Dr, PhD
- Email: a.sauvadet@fr.urgo.com
- Phone: +33 6 71 19 78 91
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Vacuum Compression Therapy for Venous Leg Ulcers
This study tests whether adding vacuum compression therapy to standard wound care helps heal chronic venous leg ulcers by increasing local tissue oxygenation.
-
Human placental membrane products plus standard care for nonhealing diabetic foot and venous leg ulcers
This trial will try human placental membrane products together with standard wound care to help adults whose diabetic foot ulcers or venous leg ulcers have not healed.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.