Compression Device Versus 4-layer Compression System

Phase 2

Completed

• Conditions: Leg Ulcers
• Interventions: Device: Compression Device; Device: Profore

• Registration Number: NCT00821431
• Lead Sponsor: ConvaTec Inc.

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

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Results First Submitted: 2014-09-03
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-08
• Last Update Submitted: 2015-01-08
• Results First Posted: 2015-01-09
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compression device	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.
Profore, 4-layer bandage	Profore	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.

Primary Outcome Measures

Name	Time	Method
Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Healing Measured by Number of Subjects Healed During the 12 Week Study Period	12 weeks

Trial Locations

Locations (18)

Private Practice; 🇩🇪 Hamburg, Germany

Groupe Hospitalier Saint-Joseph; 🇫🇷 Paris, France

Hautarzt Phlebologe Allergologe; 🇩🇪 Freiburg, Germany

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

Short Health Clinic; 🇬🇧 Willenhall, United Kingdom

Arrowe Park Hospital; 🇬🇧 Upton, United Kingdom

The Adelaide & Meath Hospital; 🇮🇪 Dublin, Ireland

Mid-Western Regional Hospital; 🇮🇪 Limerick, Ireland

Cork University Hospital; 🇮🇪 Wilton, Ireland