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Compression Device Versus 4-layer Compression System

Primary Purpose

Leg Ulcers

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Compression Device
Profore
Sponsored by
ConvaTec Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Private Practice
  • Groupe Hospitalier Saint-Joseph
  • Hautarzt Phlebologe Allergologe
  • Private Practice
  • Private Practice
  • The Adelaide & Meath Hospital
  • Mid-Western Regional Hospital
  • Cork University Hospital
  • Dermatology Day Unit; Monklands Hospital
  • The Wilson Practice, Alton Health Centre
  • Wound Healing Research Unit; Cardiff University
  • Tissue Viability Consultancy
  • Institute of Wound Care, The University of Hull
  • Diving Diseases Research Centre, Hyperbaric Medical Centre
  • University Dept of Vascular
  • Medical Physics & Bioengineering, Southampton University Hospital
  • Department of Vascular Surgery, Good Hope Hospital
  • Trowbridge Community Hospital
  • Arrowe Park Hospital
  • Short Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Compression device

Profore, 4-layer bandage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)

Secondary Outcome Measures

Healing Measured by Number of Subjects Healed During the 12 Week Study Period

Full Information

First Posted
January 9, 2009
Last Updated
January 8, 2015
Sponsor
ConvaTec Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00821431
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConvaTec Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compression device
Arm Type
Experimental
Arm Description
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.
Arm Title
Profore, 4-layer bandage
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Compression Device
Intervention Description
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
Intervention Name(s)
Profore
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Healing Measured by Number of Subjects Healed During the 12 Week Study Period
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathon Hopper, MD
Organizational Affiliation
ConvaTec Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Private Practice
City
Neuilly sur Seine
Country
France
Facility Name
Groupe Hospitalier Saint-Joseph
City
Paris
Country
France
Facility Name
Hautarzt Phlebologe Allergologe
City
Freiburg
Country
Germany
Facility Name
Private Practice
City
Gilching
Country
Germany
Facility Name
Private Practice
City
Hamburg
Country
Germany
Facility Name
The Adelaide & Meath Hospital
City
Dublin
Country
Ireland
Facility Name
Mid-Western Regional Hospital
City
Limerick
Country
Ireland
Facility Name
Cork University Hospital
City
Wilton
Country
Ireland
Facility Name
Dermatology Day Unit; Monklands Hospital
City
Airdrie
Country
United Kingdom
Facility Name
The Wilson Practice, Alton Health Centre
City
Alton
Country
United Kingdom
Facility Name
Wound Healing Research Unit; Cardiff University
City
Cardiff
Country
United Kingdom
Facility Name
Tissue Viability Consultancy
City
Eastbourne
Country
United Kingdom
Facility Name
Institute of Wound Care, The University of Hull
City
Hull
Country
United Kingdom
Facility Name
Diving Diseases Research Centre, Hyperbaric Medical Centre
City
Plymouth
Country
United Kingdom
Facility Name
University Dept of Vascular
City
Solihull
Country
United Kingdom
Facility Name
Medical Physics & Bioengineering, Southampton University Hospital
City
Southampton
Country
United Kingdom
Facility Name
Department of Vascular Surgery, Good Hope Hospital
City
Sutton Coldfield
Country
United Kingdom
Facility Name
Trowbridge Community Hospital
City
Trowbridge
Country
United Kingdom
Facility Name
Arrowe Park Hospital
City
Upton
Country
United Kingdom
Facility Name
Short Health Clinic
City
Willenhall
Country
United Kingdom

12. IPD Sharing Statement

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Compression Device Versus 4-layer Compression System

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