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).
Study Type
OBSERVATIONAL
Enrollment
600
Clinical evaluation of the dressing in the local treatment of chronic wounds (DFU and VLU)
Pr Agnès HARTEMANN
Paris, France
RECRUITINGNumber 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
Time frame: 12 weeks
Time to wound closure
For healed patients: time to wound closure (in days)
Time frame: 12 weeks
Relative reduction in wound surface area
Relative reduction in wound surface area (in %) during intermediate and final visits
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Defectuosity of the device
Description of the defects of the devices used.
Time frame: 12 weeks
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