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NCT06135987 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

— STARTLIFE  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06135987
Other study ID # 2021-A02414-37
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 24, 2022
Est. completion date October 2024

Study information
Verified date November 2023
Source Laboratoires URGO
Contact Anne SAUVADET, PhD
Phone +33380442884
Email a.sauvadet@fr.urgo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date October 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
France Pr Agnès HARTEMANN Paris

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires URGO

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with complete healed chronic wound (venous leg ulcer and Diabetic foot ulcer) at 12 weeks Complete ulcer closure (100% re-epithelialization) over 12 weeks of treatment with UrgoStart Plus® Border, UrgoStart Plus® pad and UrgoStart Interface® dressings 12 weeks
Secondary Time to wound closure For healed patients: time to wound closure (in days) 12 weeks
Secondary Relative reduction in wound surface area Relative reduction in wound surface area (in %) during intermediate and final visits 12 weeks
Secondary EQ5D5L quality of life questionnaire The evolution of the patient quality of life assessed with the EuroQoL 5D-5L will be evaluated between baseline and at last visit. 12 weeks
Secondary Tolerance : the nature and number of adverse event related to the use of the testing dressings 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. 12 weeks
Secondary Defectuosity of the device Description of the defects of the devices used. 12 weeks
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