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

NCT05772507 | Unknown

• 1 other identifier: IDRCB no.: 2022-A00862-41
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• relative wound area reduction (RWAR)

  changes in the area of wounds after 4 weeks of treatment.

  4 week treatment period

Secondary Outcomes (2)

• percentage of patients whose wound has healed

  4 week treatment period

• Nature and incidence of Treatment Adverse Effects as assessed in percentage for each dressing

  4 week treatment period

Study Arms (1)

medical device under investigation

EXPERIMENTAL

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

Interventions

URGO AWC_008 dressing or URGO AWC_022 dressing DEVICE

local management of acute or chronic wounds

medical device under investigation

Eligibility Criteria

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

You may qualify if:

• 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,

You may not qualify if:

• Patient with a serious general condition, that could lead to withdrawal from the trial before four weeks of treatment,
• Patient with a systemic infection
• Wound totally or partially covered on its surface with a black plaque of necrosis,
• Cancerous wound

Sponsors & Collaborators

• Laboratoires URGO: lead

Study Sites (1)

URGO

Dijon, France

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer; Wound Infection

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 16, 2023
• Study Start: August 22, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)