Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Leg Ulcer Clinical Trial

Official title:

An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591434
• Other study ID #: CW-0209-11-U361
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2012
• Last updated: July 29, 2013
• Start date: May 2012
• Est. completion date: September 2012

Study information

• Verified date: July 2013
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer

Intervention

Device:
• AQUACEL®
Dressing to be changed as clinically needed or at least every seven days.
• AQUACEL® Extra™
Dressing to be changed as clinically needed or at least every seven days.

Locations

Country	Name	City	State
Germany	Dermatologische Gemeinschaftspraxis	Freiburg
Germany	Bramfelder Chaussee	Hamburg
Netherlands	Mitralis Expertise Centrum	Heerlen
Poland	Nzoz Certus	Lódz
Poland	Continuum Care	Warsaw
Poland	CF Centrum Flebologii Anna i Beata Narojczyk	Warszawa
Poland	Medyczna "Medservice"	Zabrze
United Kingdom	Bradford Teaching Hospitals	Bradford
United Kingdom	Wound Healing Research Unit, Cardiff University	Cardiff
United Kingdom	Tissue Viability Consultancy Services Ltd	Eastbourne
United Kingdom	Arrowe Park Hospital,	Upton	Wirral
United Kingdom	Walsall Healthcare NHS Trust Short Heath Clinic	Willenhall

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Countries where clinical trial is conducted

Germany,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wear Time	frequency of dressing changes	4 weeks	No
Primary	Wear Time	Reason for dressing changes	4 weeks	No
Primary	% of dressings achieving a 7 day wear time		4 weeks	No
Primary	Time to achieve a 7 day wear time		4 weeks	No
Primary	Condition of the peri-ulcer skin	Improvement from baseline in the condition of the peri-ulcer skin	4 weeks	No