Clinical trial NCT06135987: Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Real Life Study
TLC-NOSF Dressings
Venous Leg Ulcer
Diabetic Foot Ulcer
QoL Questionnaire
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients participating in this clinical evaluation suffering of:

* a predominantly venous or mixed leg ulcer,
* or a neuropathic or neuroischemic diabetic foot ulcer (without critical ischemia) that the investigating physician has decided to treat with one or other of the 3 following dressing containing TLC-NOSF : UrgoStart Plus® Border, UrgoStart Plus® Pad or UrgoStart Interface®

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with complete healed chronic wound (venous leg ulcer and Diabetic foot ulcer) at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to wound closure
timeFrame: 12 weeks
measure: Relative reduction in wound surface area
timeFrame: 12 weeks
measure: EQ5D5L quality of life questionnaire
timeFrame: 12 weeks
measure: Tolerance : the nature and number of adverse event related to the use of the testing dressings
timeFrame: 12 weeks
measure: Defectuosity of the device
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Pr Agnès HARTEMANN
Study officials:
References: