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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772507
• Other study ID #: IDRCB no.: 2022-A00862-41
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2023
• Source: Laboratoires URGO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Wounds
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Infections
• Leg Ulcer
• Pressure Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• URGO AWC_008 dressing or URGO AWC_022 dressing
local management of acute or chronic wounds

Locations

Country	Name	City	State
France	URGO	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative wound area reduction (RWAR)	changes in the area of wounds after 4 weeks of treatment.	4 week treatment period
Secondary	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
Secondary	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