Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)

NCT06135987 | Unknown

• 1 other identifier: 2021-A02414-37
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Real Life Study; TLC-NOSF Dressings; Venous Leg Ulcer; Diabetic Foot Ulcer; QoL Questionnaire

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Time to wound closure

  12 weeks

• Relative reduction in wound surface area

  12 weeks

• EQ5D5L quality of life questionnaire

  12 weeks

• Tolerance : the nature and number of adverse event related to the use of the testing dressings

  12 weeks

• Defectuosity of the device

  12 weeks

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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®

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Laboratoires URGO: lead

Study Sites (1)

Pr Agnès HARTEMANN

Paris, 75000, France

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Anne SAUVADET, PhD

CONTACT

+33380442884; a.sauvadet@fr.urgo.com

Olivier TACCA, PhD

CONTACT

+33380447422; o.tacca@fr.urgo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 18, 2023
• Study Start: June 24, 2022
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)