MedTrace Logo

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

NCT06899919 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-04-08

No results posted yet for this study

Summary

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

  • Leg Ulcers

Interventions

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

Sponsors & Collaborators

  • Laboratoires URGO

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-29
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06899919 on ClinicalTrials.gov