Compression Device Versus 4-layer Compression System

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.

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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcers
• Intervention / Treatment: Device: Compression Device; Device: Profore

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Healing Measured by Number of Subjects Healed During the 12 Week Study Period	12 weeks

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Study Director: Jonathon Hopper, MD, ConvaTec Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 9, 2009
• First Submitted That Met QC Criteria: January 12, 2009
• First Posted (Estimate): January 13, 2009

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Leg Ulcer
• Other Study ID Numbers: CW-0500-05-U342