Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
This study has been completed.
Sponsor:
ConvaTec Inc.
Information provided by (Responsible Party):
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01591434
First received: May 2, 2012
Last updated: September 18, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leg Ulcer |
Device: AQUACEL® Device: AQUACEL® Extra™ |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers |
Resource links provided by NLM:
Further study details as provided by ConvaTec Inc.:
Primary Outcome Measures:
- Wear Time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]frequency of dressing changes
- Wear Time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Reason for dressing changes
- % of dressings achieving a 7 day wear time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Time to achieve a 7 day wear time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Condition of the peri-ulcer skin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Improvement from baseline in the condition of the peri-ulcer skin
| Enrollment: | 65 |
| Study Start Date: | May 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: AQUACEL®
A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC).
|
Device: AQUACEL®
Dressing to be changed as clinically needed or at least every seven days.
|
|
Active Comparator: AQUACEL® Extra™
A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns.
|
Device: AQUACEL® Extra™
Dressing to be changed as clinically needed or at least every seven days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591434
Locations
| Germany | |
| Dermatologische Gemeinschaftspraxis | |
| Freiburg, Germany, 79100 | |
| Bramfelder Chaussee | |
| Hamburg, Germany | |
| Netherlands | |
| Mitralis Expertise Centrum | |
| Heerlen, Netherlands, 6401 CX | |
| Poland | |
| Continuum Care | |
| Warsaw, Poland, 18, 02-366 | |
| CF Centrum Flebologii Anna i Beata Narojczyk | |
| Warszawa, Poland, 03-983 | |
| Medyczna "Medservice" | |
| Zabrze, Poland, 41-819 | |
| Nzoz Certus | |
| Łódź, Poland, 90-553 | |
| United Kingdom | |
| Arrowe Park Hospital, | |
| Upton, Wirral, United Kingdom, CH49 5PE | |
| Bradford Teaching Hospitals | |
| Bradford, United Kingdom, BD9 6RJ | |
| Wound Healing Research Unit, Cardiff University | |
| Cardiff, United Kingdom, CF14 4XN | |
| Tissue Viability Consultancy Services Ltd | |
| Eastbourne, United Kingdom, BN21 4RL | |
| Walsall Healthcare NHS Trust Short Heath Clinic | |
| Willenhall, United Kingdom, WV12 5PR | |
Sponsors and Collaborators
ConvaTec Inc.
Investigators
| Principal Investigator: | Keith G Harding | Cardiff University |
More Information
No publications provided
| Responsible Party: | ConvaTec Inc. |
| ClinicalTrials.gov Identifier: | NCT01591434 History of Changes |
| Other Study ID Numbers: | CW-0209-11-U361 |
| Study First Received: | May 2, 2012 |
| Last Updated: | September 18, 2012 |
| Health Authority: | United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Leg Ulcer Ulcer Varicose Ulcer Skin Ulcer Skin Diseases Pathologic Processes Varicose Veins |
Vascular Diseases Cardiovascular Diseases Carboxymethylcellulose Sodium Laxatives Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013