Compression Device Versus 4-Layer Compression System - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 9, 2009

Last Updated Date

January 12, 2009

Start Date ^†

May 2006

Current Primary Outcome Measures ^†

Safety measured by the nature and frequency of adverse events (including any deterioration of ulcer) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00821431 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Healing measured by number and proportion of subjects healed during the 12 week study period, time to healing and reduction in ulcer area. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Compression Device Versus 4-Layer Compression System

Official Title ^†

A Phase II Study to Compare the Effect of a Compression Device to That of a 4-Layer Compression System on Subjects With Venous Leg Ulcers.

Brief Summary

A prospective, Phase II, stratified, randomized study to compare the safety, ulcer healing, patient compliance (concordance) and resource utilisation of a compression device with IPC mode to a Class 3(c) UK standard graduated compression regime (4- layer system) on subjects with venous leg ulcers.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Leg Ulcers

Intervention ^†

Device: Compression Device
Device: Profore

Study Arms / Comparison Groups

Experimental: The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.
Active Comparator: A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Subjects over 18 years, willing and able to provide written informed consent
Subjects able to wear the compression device and the comparative regime and follow the requirements of the clinical investigation plan
Subjects who had an ankle to brachial pressure index (ABPI) of 0.8 or greater
Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) 2 cm2 in size or greater, who required graduated compression
Subjects who were outpatients

Exclusion Criteria:

Subjects with a history of skin sensitivity to any of the components of the study product, comparator product or standard dressings
*Subjects with more than one ulcer on the test leg
Subjects who had previously been entered into the study or a previous Amadeus study (U327, U332 or U337) or had participated in a previous clinical study within the past 3 months
Subjects with any condition that prevented application and removal of the device without external assistance
Subjects who had an active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
Subjects who exhibited any other medical condition which, according to the Investigator, justified the subject's exclusion from the study
Subjects who had leg sizes outside the following range:
- Ankle - 12cm to 44cm
- Calf - 22cm to 60cm
- Below knee - 22cm to 68cm
Subjects who had an index venous leg ulcer greater in size than 10cm in any one dimension
Diabetic subjects with advanced small vessel disease
Denotes the exclusion criterion was amended and approved by the Ethics Committees as follows:
Amendment #1 dated 27th March 2007:
- Diabetic subjects who, in the opinion of the investigator, were not in reasonable metabolic control or had a history of hospitalisation within the last six months for the management of blood sugar and/or diabetic subjects with advanced small vessel disease
Amendment #2 dated 2nd August 2007:
- Subjects who had an index venous leg ulcer greater in size than 15cm in any one dimension
Amendment #3 dated 5th October 2007:
- Deletion of exclusion criterion 'Subjects with more than one ulcer on the test leg' to permit inclusion of subjects with multiple ulcers on the test leg

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France, Germany, Ireland, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00821431

Responsible Party

Dheerendra Kommala, MD, ConvaTec Inc.

Secondary IDs ^††

Study Sponsor ^†

ConvaTec Inc.

Collaborators ^††

Investigators ^†

Study Director:

Jonathon Hopper, MD

ConvaTec Inc.

Information Provided By

ConvaTec Inc.

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.