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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

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

Intervention / Treatment
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* Device: TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to wound closure | For healed patients: time to wound closure (in days) | 12 weeks | 
| Relative reduction in wound surface area | Relative reduction in wound surface area (in %) during intermediate and final visits | 12 weeks | 
| 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 | 
| 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 | 
| Defectuosity of the device | Description of the defects of the devices used. | 12 weeks |