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

Convatec

Status and phase

Completed

Phase 4

Conditions

Leg Ulcer

Treatments

Device: AQUACEL® Ag

Device: Urgotul® Silver

Study type

Interventional

Funder types

Industry

Identifiers

NCT01084577

CW-0142-09-U354

Details and patient eligibility

About

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.

Enrollment

266 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).