Leg Ulcer
Conditions
Brief summary
Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.
Interventions
DEVICEAQUACEL®
Dressing to be changed as clinically needed or at least every seven days.
DEVICEAQUACEL® Extra™
Dressing to be changed as clinically needed or at least every seven days.
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 1) with duration less than 24 months * Subjects whose ulcer is no smaller than 2cms in any one direction * Subjects whose ulcer is no greater than 11cm in any one direction (measured by longest length and widest width) * Subjects' whose index leg ulcer has a moderate to heavy level of exudate. * Subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control * Subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required.
Exclusion criteria
* Subjects with a history of skin sensitivity to any of the components of the study dressings (AQUACEL® Extra™, AQUACEL®, & DuoDERM™ Extra Thin) * Subjects whose wounds are considered clinically infected at baseline * Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months. * Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents * Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study * Subjects who have participated in a clinical study within the past month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wear Time | 4 weeks | frequency of dressing changes |
| % of dressings achieving a 7 day wear time | 4 weeks | — |
| Time to achieve a 7 day wear time | 4 weeks | — |
| Condition of the peri-ulcer skin | 4 weeks | Improvement from baseline in the condition of the peri-ulcer skin |
Countries
Germany, Netherlands, Poland, United Kingdom
Outcome results
None listed