NCT06899919

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Laboratoires URGO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Leg Ulcers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-29
• Primary completion: 2027-03-31
• Completion: 2027-09-30
• First posted: 2025-03-28
• Last updated: 2025-04-08

Locations

3 sites across 1 country: France