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Efficacy and Safety of URGOBD001 Compression System

NCT05158764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2023-10-17

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 the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification

Etiological treatment of venous disease of the lower limbs stage C6 / C6r

Sponsors & Collaborators

  • Laboratoires URGO

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2023-07-06
Completion
2023-10-16

Countries

  • France

Study Locations

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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 NCT05158764 on ClinicalTrials.gov