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

Recruiting

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

• Registration Number: NCT06135987
• Lead Sponsor: Laboratoires URGO

Brief 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).

Study Timeline

• Study Start: 2022-06-24
• Study First Submitted: 2023-10-16
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-06
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Adult outpatient having signed informed consent
• Patient with a venous leg ulcer (VLU) Or with a diabetic foot ulcer (DFU)
• Prescription of one of the 3 dressings: UrgoStart Plus® Border, UrgoStart Plus® pad or UrgoStart Interface®
• Patient can be followed over 12 weeks by the investigator, according to his/her practices
• Patient able to participate in the study and complete a self-questionnaire without difficulty

Exclusion Criteria

• Hemorrhagic wound
• Cancerous wound
• Fistulous wound revealing a deep abscess
• Presence of dry necrosis partially or completely covering the wound bed
• Infected wound
• Osteitis
• Critical or acute ischemia
• Patient for whom a surgical procedure related to the treated wound is scheduled within 12 weeks following the inclusion visit
• Patient with known sensitivity to one of the studied dressings components
• Pregnant or breastfeeding patient
• Patient under the protection of justice or under guardianship or deprived of liberty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with complete healed chronic wound (venous leg ulcer and Diabetic foot ulcer) at 12 weeks	12 weeks	Complete ulcer closure (100% re-epithelialization) over 12 weeks of treatment with UrgoStart Plus® Border, UrgoStart Plus® pad and UrgoStart Interface® dressings

Secondary Outcome Measures

Name	Time	Method
Time to wound closure	12 weeks	For healed patients: time to wound closure (in days)
EQ5D5L quality of life questionnaire	12 weeks	The evolution of the patient quality of life assessed with the EuroQoL 5D-5L will be evaluated between baseline and at last visit.
Relative reduction in wound surface area	12 weeks	Relative reduction in wound surface area (in %) during intermediate and final visits
Tolerance : the nature and number of adverse event related to the use of the testing dressings	12 weeks	The nature and number of adverse event related to the use of the testing dressings (UrgoStart Plus® Border, UrgoStart Plus® pad and UrgoStart Interface® dressings) (serious/ non-serious) will be described.
Defectuosity of the device	12 weeks	Description of the defects of the devices used.

Trial Locations

Locations (1)

Pr Agnès HARTEMANN; 🇫🇷 Paris, France