AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

Study Overview
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Brief Summary
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A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.

Official Title
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A Prospective, Multi-centre, Randomized, Open-label, Parallel, Comparative Study to Evaluate Effects of AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

Conditions
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Leg Ulcer

Intervention / Treatment
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* Device: AQUACEL® Ag
* Device: Urgotul® Silver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects over 18 years, willing and able to provide written informed consent. Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater. Subjects who have a venous leg ulcer (i.e. CEAP classification of C6), with duration less than 24 months and size ranging between 5 cm2-40 cm2 . Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, oedema, foul odour, and heavy exudation. Subjects agree to wear compression therapy daily in combination with the trial dressing. Exclusion Criteria: Subjects with a history of skin sensitivity to any of the components of the study product. Subjects who have had current local or systemic antibiotics in the week prior to inclusion. Subjects whose leg ulcers are clinically infected or erysipelas, malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months. Subjects who have a progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids. Subjects who have participated in a clinical study within the past 3 months. Subjects who are pregnant or breastfeeding (in accordance with the Urgotul® Silver package insert).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Urgotul® Silver<br>Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks. | Device: Urgotul® Silver<br>* Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.<br>|
| Active Comparator: AQUACEL® Ag<br>AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks. | Device: AQUACEL® Ag<br>* AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound area reduction from baseline (relative) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound closure |  | 8 weeks | 
| Clinical evolution of the wound | presence of each of the 5 selected clinical signs | 8 weeks | 
| Tolerance | occurrence of local adverse events | 8 weeks |