Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Wound Infection; Acute Wounds; Pressure Ulcer
• Interventions: Device: URGO AWC_008 dressing or URGO AWC_022 dressing

• Registration Number: NCT05772507
• Lead Sponsor: Laboratoires URGO

Brief Summary

Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection

Detailed Description

prospective multicenter, non comparative clinical investigation

This is a prospective multicenter, non comparative open-label, clinical investigation conducted in patients with acute and chronic wounds at risk of local infection or with clinical signs of local infection.

This study is carried out in France and Spain in around 30 investigator sites. A total of 85 patients meeting the eligibility criteria will be included. The patients will be followed for 4 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers.

A planimetric survey of the studied wounds is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 1, Week 2, Week 3 and Week 4).

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-16
• Study Start: 2023-08-22
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26
• Primary Completion: 2024-07
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

• Patient with a wound for which treatment in a hyperbaric chamber is planned within 4 weeks following inclusion,
• Patient with a serious general condition, that could lead to withdrawal from the trial before four weeks of treatment,
• Patient who has experienced an acute ischaemic event (acute myocardial infarction or stroke) during the 3 months prior to inclusion in the investigation,
• Patient with a systemic infection
• Wound totally or partially covered on its surface with a black plaque of necrosis,
• Cancerous wound

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
medical device under investigation	URGO AWC_008 dressing or URGO AWC_022 dressing	URGO AWC_008 or URGO AWC_022 dressing. These 2 dressings are similar and only the adhesive constitutes a difference. The choice of study dressing will be left to the discretion of the investigator during the treatment of the patient, depending on the nature of the wound and the condition of the peri-wound skin.

Primary Outcome Measures

Name	Time	Method
relative wound area reduction (RWAR)	4 week treatment period	changes in the area of wounds after 4 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
percentage of patients whose wound has healed	4 week treatment period	Complete closure of the Venous Leg Ulcer (VLU) - Healing of the wound is defined by 100% re-epithelialization of the wound
Nature and incidence of Treatment Adverse Effects as assessed in percentage for each dressing	4 week treatment period	Safety analysis with nature and number of adverse event related to the use of the dressings (serious/ non-serious)

Trial Locations

Locations (1)

URGO; 🇫🇷 Dijon, France