An observational study in Real Life Study, TLC-NOSF Dressings and Venous Leg Ulcer, sponsored by Laboratoires URGO. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Laboratoires URGO · Observational
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).
384 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's planned enrollment of 600 is above the median of 150 across 41 observational studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Laboratoires URGO is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
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Patients participating in this clinical evaluation suffering of:
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Exclusion Criteria:
Clinical evaluation of the dressing in the local treatment of chronic wounds (DFU and VLU)
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
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
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Laboratoires URGO