NCT06135987

Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)

Clinical Evaluation of URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE® in the Local Treatment of Diabetic Foot Ulcers and Venous Leg Ulcer of Mixed Etiology : French Prospective and Multicentric Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Laboratoires URGO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life conditions and current practice, in France.

Detailed description

This is an observational, non-interventional, prospective multicenter study, carried out in real-life conditions on CE marked medical devices used for their intended purpose. The study will be carried out in France, in accordance with national and European regulations (RDM 2017/745).

Conditions

• Real Life Study
• TLC-NOSF Dressings
• Venous Leg Ulcer
• Diabetic Foot Ulcer
• QoL Questionnaire

Interventions

Type	Name	Description
DEVICE	TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®)	Clinical evaluation of the dressing in the local treatment of chronic wounds (DFU and VLU)

Timeline

• Start date: 2022-06-24
• Primary completion: 2024-06-01
• Completion: 2024-10-01
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: France