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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

URGO AWC_008 dressing or URGO AWC_022 dressing

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

URGORecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

medical device under investigation

Arm Description

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.

Outcomes

Primary Outcome Measures

relative wound area reduction (RWAR)

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

Secondary Outcome Measures

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

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)

Full Information

NCT ID

NCT05772507

First Posted

March 2, 2023

Last Updated

September 25, 2023

Sponsor

Laboratoires URGO

1. Study Identification

Unique Protocol Identification Number

NCT05772507

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 22, 2023 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoires URGO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

medical device under investigation

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

URGO AWC_008 dressing or URGO AWC_022 dressing

Intervention Description

local management of acute or chronic wounds

Primary Outcome Measure Information:

Title

relative wound area reduction (RWAR)

Description

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

Time Frame

4 week treatment period

Secondary Outcome Measure Information:

Title

percentage of patients whose wound has healed

Description

Complete closure of the Venous Leg Ulcer (VLU) - Healing of the wound is defined by 100% re-epithelialization of the wound

Time Frame

4 week treatment period

Title

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

Description

Safety analysis with nature and number of adverse event related to the use of the dressings (serious/ non-serious)

Time Frame

4 week treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Facility Information:

Facility Name

URGO

City

Dijon

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clemence TUMBA, PharmD

Phone

+33 3 80 44 74 09

Email

c.tumba@fr.urgo.com

First Name & Middle Initial & Last Name & Degree

Olivier TACCA, PhD

Phone

+33 3 80 44 74 22

Email

o.tacca@fr.urgo.com

First Name & Middle Initial & Last Name & Degree

Ulrique Michon-Pasturel, MD

12. IPD Sharing Statement

Plan to Share IPD

No

Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial