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Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)

NCT04613687 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-11-03

No results posted yet for this study

Summary

The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Compression bandage

Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous

Sponsors & Collaborators

  • Laboratoires URGO

    lead INDUSTRY

Principal Investigators

  • Senet Patricia, MD · Vascular dermatologist, APHP, Paris, France

  • Dissemond Joachim, MD · Clinic for dermatology, Essen- Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2021-09-30
Completion
2021-09-30

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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 NCT04613687 on ClinicalTrials.gov