Leg Ulcer
Conditions
Brief summary
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.
Interventions
DEVICEAQUACEL® Ag
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
DEVICEUrgotul® Silver
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
Sponsors
ConvaTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound area reduction from baseline (relative) | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound closure | 8 weeks | — |
| Clinical evolution of the wound | 8 weeks | presence of each of the 5 selected clinical signs |
| Tolerance | 8 weeks | occurrence of local adverse events |
Countries
Denmark, France, Germany, Poland, United Kingdom
Outcome results
None listed