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

Assessment of the Efficacy and Tolerance of 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

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

Study Overview

• Status: Recruiting
• Conditions: Wound Infection; Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer; Acute Wounds
• Intervention / Treatment: Device: URGO AWC_008 dressing or URGO AWC_022 dressing

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 Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France
    • Recruiting
    • URGO
    • Principal Investigator: Ulrique MICHON-PASTUREL, MD
    • Contact: Clemence TUMBA, PharmD; Phone Number: +33 3 80 44 74 09; Email: c.tumba@fr.urgo.com
    • Contact: Olivier TACCA, PhD; Phone Number: +33 3 80 44 74 22; Email: o.tacca@fr.urgo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria :

Related to all wounds :

• Adult patient having given free, informed and written consent
• Patient affiliated to a social security insurance scheme (applicable For France),
• Inpatient or outpatient who can be followed by the same investigative team throughout the investigation,
• Acute wound (burn, traumatic wound, unstitched surgical wound) or chronic wound (leg ulcer, pressure ulcer, diabetic foot ulcer),
• Wound whose surface can be covered by a single dressing,
• Wound at least 3 cm from any edge of another wound.

Related to acute wounds, leg ulcer, pressure ulcer:

Patient whose studied wound presents a risk of local infection (based on modified W.A.R. score ≥ 3 points) or with at least 3 of the following clinical signs:

• Pain (spontaneous, pressure pain or increased pain),
• Peri-wound erythema,
• Oedema, induration or swelling,
• Odour (increase, change),
• Exudate (colour modification or increase of exudate),
• Local warmth,
• Hypergranulation,
• Bleeding, friable granulation tissue,
• Stagnant healing/wound deterioration.

Related to diabetic foot ulcer :

Patient whose studied wound presents a risk of local infection (based on modified W.A.R. score ≥ 3 points) or with at least 2 of the following clinical signs:

• Pain (spontaneous, pressure pain or increased pain),
• Peri-wound erythema between 0.5-2.0 cm around the wound,
• Oedema, induration or swelling,
• Odour (increase, change),
• Exudate (colour modification or increase of exudate),
• Local warmth,
• Hypergranulation,
• Bleeding, friable granulation tissue,
• Stagnant healing/wound deterioration,

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: medical device under investigation; 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.	Device: URGO AWC_008 dressing or URGO AWC_022 dressing; local management of acute or chronic wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relative wound area reduction (RWAR)	changes in the area of wounds after 4 weeks of treatment.	4 week treatment period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laboratoires URGO

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Infections; Wounds and Injuries; Wound Infection; Leg Ulcer; Varicose Ulcer; Pressure Ulcer
• Other Study ID Numbers: IDRCB no.: 2022-A00862-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No