Clinical trial NCT01591434: Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
Official title: An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leg Ulcer
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Wear Time
timeFrame: 4 weeks
measure: Wear Time
timeFrame: 4 weeks
measure: % of dressings achieving a 7 day wear time
timeFrame: 4 weeks
measure: Time to achieve a 7 day wear time
timeFrame: 4 weeks
measure: Condition of the peri-ulcer skin
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Dermatologische Gemeinschaftspraxis
city: Hamburg
country: Germany
facility: Bramfelder Chaussee
city: Heerlen
country: Netherlands
facility: Mitralis Expertise Centrum
city: Warsaw
country: Poland
facility: Continuum Care
city: Warszawa
country: Poland
facility: CF Centrum Flebologii Anna i Beata Narojczyk
city: Zabrze
country: Poland
facility: Medyczna "Medservice"
city: Łódź
country: Poland
facility: Nzoz Certus
city: Upton
country: United Kingdom
facility: Arrowe Park Hospital,
state: Wirral
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals
city: Cardiff
country: United Kingdom
facility: Wound Healing Research Unit, Cardiff University
city: Eastbourne
country: United Kingdom
facility: Tissue Viability Consultancy Services Ltd
city: Willenhall
country: United Kingdom
facility: Walsall Healthcare NHS Trust Short Heath Clinic
Study officials:
affiliation: Cardiff University
name: Keith G Harding
role: PRINCIPAL_INVESTIGATOR
References: