NCT05772507

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Laboratoires URGO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Foot Ulcer
• Venous Leg Ulcer
• Pressure Ulcer
• Wound Infection
• Acute Wounds

Interventions

Type	Name	Description
DEVICE	URGO AWC_008 dressing or URGO AWC_022 dressing	local management of acute or chronic wounds

Timeline

• Start date: 2023-08-22
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2023-03-16
• Last updated: 2023-09-26

Locations

1 site across 1 country: France