Compression Device Versus 4-Layer Compression System - Full Text View

Sponsored by:	ConvaTec Inc.
Information provided by:	ConvaTec Inc.
ClinicalTrials.gov Identifier:	NCT00821431

Purpose

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.

Condition	Intervention	Phase
Leg Ulcers	Device: Compression Device Device: Profore	Phase II

MedlinePlus related topics: Leg Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by ConvaTec Inc.:

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 ]

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 ]

Enrollment:	90
Study Start Date:	May 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Compression device: 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.	Device: Compression Device Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressurs: Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg. Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day.
Profore, 4-layer bandage: 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.	Device: Profore Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert.

Arms

Assigned Interventions

Compression device: 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.

Device: Compression Device

Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressurs:

Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.

Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day.

Profore, 4-layer bandage: 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.

Device: Profore

Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821431

Locations

France
Private Practice
Neuilly sur Seine, France
Groupe Hospitalier Saint-Joseph
Paris, France
Germany
Hautarzt Phlebologe Allergologe
Freiburg, Germany
Private Practice
Hamburg, Germany
Private Practice
Gilching, Germany
Ireland
Cork University Hospital
Wilton, Ireland
Mid-Western Regional Hospital
Limerick, Ireland
The Adelaide & Meath Hospital
Dublin, Ireland
United Kingdom
Wound Healing Research Unit; Cardiff University
Cardiff, United Kingdom
Dermatology Day Unit; Monklands Hospital
Airdrie, United Kingdom
The Wilson Practice, Alton Health Centre
Alton, United Kingdom
Arrowe Park Hospital
Upton, United Kingdom
Medical Physics & Bioengineering, Southampton University Hospital
Southampton, United Kingdom
Diving Diseases Research Centre, Hyperbaric Medical Centre
Plymouth, United Kingdom
Institute of Wound Care, The University of Hull
Hull, United Kingdom
Department of Vascular Surgery, Good Hope Hospital
Sutton Coldfield, United Kingdom
Tissue Viability Consultancy
Eastbourne, United Kingdom
University Dept of Vascular
Solihull, United Kingdom
Short Health Clinic
Willenhall, United Kingdom
Trowbridge Community Hospital
Trowbridge, United Kingdom

Sponsors and Collaborators

ConvaTec Inc.

Investigators

Study Director:

Jonathon Hopper, MD

ConvaTec Inc.

More Information

Responsible Party:	ConvaTec Inc. ( Dheerendra Kommala, MD )
Study ID Numbers:	CW-0500-05-U342
Study First Received:	January 9, 2009
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00821431
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board; France: Ministry of Health

Study placed in the following topic categories:

Skin Diseases
Ulcer
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009