Evaluation of TLC-NOSF Dressings for Chronic Wound Treatment
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
This study is testing how well TLC-NOSF dressings work for treating diabetic foot ulcers and venous leg ulcers in adults over 12 weeks in real-life settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laboratoires URGO Industry-sponsored |
| Locations | 1 site (Paris) |
| Trial ID | NCT06135987 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance and safety of TLC-NOSF dressings, specifically UrgoStart Plus® Border, UrgoStart Plus® Pad, and UrgoStart Interface®, in treating diabetic foot ulcers and venous leg ulcers under real-life conditions in France. It will involve adult outpatients who have consented to participate and will be monitored over a 12-week period. The study is designed to gather data on the effectiveness of these dressings in everyday clinical practice, adhering to national and European regulations.
Who should consider this trial
Good fit: Ideal candidates include adults with either a venous leg ulcer or a diabetic foot ulcer who can be monitored for 12 weeks.
Not a fit: Patients with infected wounds, critical ischemia, or those requiring surgical intervention within 12 weeks will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and healing of chronic wounds, enhancing patient quality of life.
How similar studies have performed: While this study focuses on a specific dressing, similar approaches in evaluating wound care products have shown promising results in improving healing outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Pr Agnès HARTEMANN — Paris, France (Recruiting)
Study contacts
- Study coordinator: Anne SAUVADET, PhD
- Email: a.sauvadet@fr.urgo.com
- Phone: +33380442884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.