Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05158764

Efficacy and Safety of URGOBD001 Compression System — FUTURE  

Venous Leg Ulcer Clinical Trial

Official title:
Evaluation of the Efficacy and Safety of the New URGO BD001 Compression System Versus a Reference Compression in the Local Treatment of Venous or Mixed Predominantly Venous Leg Ulcers: a Prospective Open-label RCT

Clinical Trial 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

Clinical Trial Description

This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a leg ulcer of venous or mixed predominantly venous origin of stage C6 / C6r of the CEAP classification. This study is carried out in around 55 French investigational centers. A total of 178 patients meeting the eligibility criteria will be included. The patients will be followed for 12 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers. A planimetric survey of the studied VLU 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05158764
Study type Interventional
Source Laboratoires URGO
Contact
Status Completed
Phase N/A
Start date December 3, 2021
Completion date October 16, 2023
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Withdrawn NCT02912858 - Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients N/A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 GrafixPL™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
Not yet recruiting NCT04613687 - Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM) 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