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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®) | Device | Clinical evaluation of the dressing in the local treatment of chronic wounds (DFU and VLU) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients participating in this clinical evaluation suffering of:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne SAUVADET, PhD | Contact | +33380442884 | a.sauvadet@fr.urgo.com | |
| Olivier TACCA, PhD | Contact | +33380447422 | o.tacca@fr.urgo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr Agnès HARTEMANN | Recruiting | Paris | 75000 | France |
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| 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 |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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