An open randomised comparative study to evaluate the performance of AQUACEL® Extra* in Venous Leg Ulcers

Phase 4

Completed

• Conditions: venous disease; venous leg ulcers; venous ulcers; 10047043

• Registration Number: NL-OMON37546
• Lead Sponsor: Kaltostat: ConvaTec; Mepilex: Molnlyke Health Care AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

The following subjects may be included in the study:;•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 larger than 2cm x 11cm
•Subjects who have only one ulcer on the index leg
•Subjects* whose index leg ulcer has a moderate to heavy level of exudate (a definition of exudate levels will be provided).
•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

The following subjects must not be included into the study:;•Subjects with a history of skin sensitivity to any of the components of the study dressings.
•Subjects whose wounds are considered clinically infected at baseline
•Subjects whose leg is oedematous (level of oedema TBC)
•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Exudate management:<br /><br>- wear time<br /><br>- % dressings achieving a 7 day wear time<br /><br>- Time to achieve a 7 day wear time<br /><br>- Condition of the peri-ulcer skin</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Besides that the following will be investigated as well: Safety, Ulcer<br /><br>improvement, Progress towards healing, Pain, Comfort, Ease of Use, Dressing<br /><br>utilisation and costs </p><br>