Clinical Trials Logo
  1. Home
  2. Venous Leg Ulcer
  3. NCT04613687

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

Venous Leg Ulcer Clinical Trial

Official title:
Evaluation of the Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of Venous or Mixed Predominantly Venous Leg Ulcers

Clinical Trial 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.

Clinical Trial Description

The compression bandage URGO BD001 is indicated for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous oedema and lymphedema justifying strong compression. The pressure applied with the compression system URGO BD001 help to improve venous return and to reduce venous oedema. The expected clinical benefits from the compression system URGO BD001 in patient with a VLU are to increase healing rate and time to healing, and to improve patient quality of life. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04613687
Study type Interventional
Source Laboratoires URGO
Contact Batot Géraldine, PhD
Phone +33 3 80 44 28 46
Email g.batot@fr.urgo.com
Status Not yet recruiting
Phase N/A
Start date October 30, 2020
Completion date September 30, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03903692 - A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers N/A
Completed NCT03257254 - Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
Recruiting NCT03666754 - Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of the Venous Ulcer N/A
Withdrawn NCT02912858 - Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients N/A
Completed NCT02482038 - Geko Venous Leg Ulcer Study N/A
Completed NCT02652572 - Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Venous Leg Ulcers Phase 1
Unknown status NCT01658618 - Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer N/A
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Completed NCT03077165 - Dose-response Relationship Study of S42909 on Leg Ulcer Healing Phase 2
Completed NCT04461132 - The Effect of Manual Lymphatic Drainage N/A
Completed NCT05974982 - Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers Phase 1
Completed NCT04011371 - Cyanoacrylate Closure for Treatment of Venous Leg Ulcers N/A
Not yet recruiting NCT03543007 - Evaluating the Safety and Efficacy of GrafixPLâ„¢PRIME for the Treatment of Chronic Venous Leg Ulcers N/A
Completed NCT03286140 - Early Venous Reflux Ablation Ulcer Trial N/A
Recruiting NCT05588583 - A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. N/A
Recruiting NCT05549609 - A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers Phase 1/Phase 2
Recruiting NCT05409976 - The GORE® VIAFORT Vascular Stent IVC Study N/A
Not yet recruiting NCT05089890 - Clinical Investigation of Sorbact® Dressings N/A
Not yet recruiting NCT03670329 - Management of Infection Risk in Non-comparative Trial (MINT) N/A
Completed NCT02921750 - Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin N/A