Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation) (PROMETHEE)

April 7, 2025 updated by: Laboratoires URGO

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a mixed (non-ischemic) leg ulcer of stage C6 / C6r of the CEAP classification.

This study is carried out in around 50 French investigational centers. A total of 210 patients meeting the eligibility criteria will be included. The patients will be followed for 16 weeks and a total of 6 clinical evaluations will be carried out by the investigating centers.

A planimetric survey of the studied leg ulcers is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 2, Week 4, Week 8 and Week 12).

A QoL is carried out at D0 and end of the study for each patient included in the protocol.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Olivier OlT TACCA, Dr, PhD
  • Phone Number: +33 3 80 44 74 22
  • Email: o.tacca@fr.urgo

Study Locations

  • France
      • Lyon, France, 69007
        • Recruiting
        • Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON
        • Contact:
      • Paris, France, 75000
        • Not yet recruiting
        • Patricia SENET, Paris, Paris 75000
        • Contact:
          • Olivier OlT TACCA, Dr, PhD
          • Phone Number: +33 3 80 44 74 22
          • Email: o.tacca@fr.urgo
        • Contact:
        • Contact:
          • Patricia PaS SENET, Dr, MD, PhD
      • Paris, France, 75970
        • Not yet recruiting
        • APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: light compression system
Treatment with two bandages light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
Device: Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
Treatment with light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
Device: Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification
Etiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification
Placebo Comparator: tubular bandage
Treatment with tubular bandage system during 16-week treament period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
Device: Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
Treatment with light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
Device: Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification
Etiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete closure of the Venous Leg Ulcer (VLU)
Time Frame: 16-week treament period
Description: Complete closure of the leg ulcer is defined by 100% re-epithelialization of the mixed Leg Ulcer (MLU)
16-week treament period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete closure of the Venous Leg Ulcer (VLU)
Time Frame: 16-week treament period
Description: Time to complete closure of the Mixed Leg Ulcer (MLU) is defined as the time from inclusion to the date of complete closure
16-week treament period
Safety analysis
Time Frame: 16-week treament period
Nature and number of adverse event related to the use of the studied light compression system and tubular bandage (serious/ non-serious and emergent)
16-week treament period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires URGO

Investigators

  • Principal Investigator: Patricia PaS SENET, Dr, MD, PhD, Hôpitaux Universitaires Paris Est (AP-HP) - Hôpital TENON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID RBC : 2024-A01402-45

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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