Compression Device Versus 4-layer Compression System

NCT ID: NCT00821431

Last Updated: 2015-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-06-30

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.

Conditions

Leg Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Compression device

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.

Group Type: EXPERIMENTAL

Compression Device

Intervention Type: 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 pressures:

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

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.

Group Type: ACTIVE_COMPARATOR

Profore

Intervention Type: DEVICE

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.

Interventions

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 pressures:

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathon Hopper, MD

Role: STUDY_DIRECTOR

ConvaTec Inc.

Locations

Private Practice

Neuilly-sur-Seine, , France

Groupe Hospitalier Saint-Joseph

Paris, , France

Hautarzt Phlebologe Allergologe

Freiburg im Breisgau, , Germany

Private Practice

Gilching, , Germany

Private Practice

Hamburg, , Germany

The Adelaide & Meath Hospital

Dublin, , Ireland

Mid-Western Regional Hospital

Limerick, , Ireland

Cork University Hospital

Wilton, , Ireland

Dermatology Day Unit; Monklands Hospital

Airdrie, , United Kingdom

The Wilson Practice, Alton Health Centre

Alton, , United Kingdom

Wound Healing Research Unit; Cardiff University

Cardiff, , United Kingdom

Tissue Viability Consultancy

Eastbourne, , United Kingdom

Institute of Wound Care, The University of Hull

Hull, , United Kingdom

Diving Diseases Research Centre, Hyperbaric Medical Centre

Plymouth, , United Kingdom

University Dept of Vascular

Solihull, , United Kingdom

Medical Physics & Bioengineering, Southampton University Hospital

Southampton, , United Kingdom

Department of Vascular Surgery, Good Hope Hospital

Sutton Coldfield, , United Kingdom

Trowbridge Community Hospital

Trowbridge, , United Kingdom

Arrowe Park Hospital

Upton, , United Kingdom

Short Health Clinic

Willenhall, , United Kingdom

Countries

France; Germany; Ireland; United Kingdom

Other Identifiers

CW-0500-05-U342

Identifier Type: -

Identifier Source: org_study_id