NCT06899919

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Mar 2025Sep 2027

First Submitted

Initial submission to the registry

March 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 29, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

March 21, 2025

Last Update Submit

April 7, 2025

Conditions

Leg Ulcers

Keywords

Mixed leg ulcersQuality of life questionnairelight compression system

Outcome Measures

Primary Outcomes (1)

  • Complete closure of the Venous Leg Ulcer (VLU)

    Description: Complete closure of the leg ulcer is defined by 100% re-epithelialization of the mixed Leg Ulcer (MLU)

    16-week treament period

Secondary Outcomes (2)

  • Time to complete closure of the Venous Leg Ulcer (VLU)

    16-week treament period

  • Safety analysis

    16-week treament period

Study Arms (2)

light compression system

EXPERIMENTAL

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)Device: Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification

tubular bandage

PLACEBO COMPARATOR

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)Device: Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification

Interventions

Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)DEVICE

Treatment with light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)

light compression systemtubular bandage
Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classificationDEVICE

Etiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification

light compression systemtubular bandage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient with a systemic infection not controlled by appropriate antibiotic therapy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Patricia SENET, Paris, Paris 75000

Paris, Paris, 75000, France

NOT YET RECRUITING

Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON

Lyon, 69007, France

RECRUITING

APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20

Paris, 75970, France

NOT YET RECRUITING

MeSH Terms

Conditions

Leg Ulcer

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Patricia PaS SENET, Dr, MD, PhD

    Hôpitaux Universitaires Paris Est (AP-HP) - Hôpital TENON

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne AnS SAUVADET, Dr, PhD

CONTACT

+33 6 71 19 78 91a.sauvadet@fr.urgo.com

Olivier OlT TACCA, Dr, PhD

CONTACT

+33 3 80 44 74 22o.tacca@fr.urgo

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomization 2:1 (light compression system vs tubular bandage)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

March 29, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 8, 2025

Record last verified: 2025-03

Locations

FR(3)