Evaluating a light compression system for treating mixed leg ulcers
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laboratoires URGO Industry-sponsored |
| Locations | 3 sites (Paris, Paris and 2 other locations) |
| Trial ID | NCT06899919 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage C6 / C6r mixed leg ulcers that meet specific clinical criteria.
Not a fit: Patients with systemic infections, severe arterial pathology, or clinically infected wounds may not benefit from this study.
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 performed: Other studies have shown promising results with similar compression therapies, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Paris, Paris and 2 other locations
- Patricia SENET, Paris, Paris 75000 — Paris, Paris, France (Not_yet_recruiting)
- Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON — Lyon, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.