Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)
Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer
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
Sites / Locations
- URGORecruiting
Arms of the Study
Arm 1
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.