Compression Device Versus 4-layer Compression System

• ClinicalTrials.gov Identifier: NCT00821431
• Recruitment Status: Completed
• First Posted: January 13, 2009
• Results First Posted: January 9, 2015
• Last Update Posted: January 9, 2015
• Sponsor: ConvaTec Inc.
• Information provided by (Responsible Party): ConvaTec Inc.

Tracking Information

• First Submitted Date: January 9, 2009
• First Posted Date: January 13, 2009
• Results First Submitted Date: September 3, 2014
• Results First Posted Date: January 9, 2015
• Last Update Posted Date: January 9, 2015
• Study Start Date: May 2006
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 8, 2015): Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer) [ Time Frame: 12 Weeks ]
• Original Primary Outcome Measures (submitted: January 12, 2009): Safety measured by the nature and frequency of adverse events (including any deterioration of ulcer) [ Time Frame: 12 Weeks ]
• Current Secondary Outcome Measures (submitted: January 8, 2015): Healing Measured by Number of Subjects Healed During the 12 Week Study Period [ Time Frame: 12 weeks ]
• Original Secondary Outcome Measures (submitted: January 12, 2009): 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 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Leg Ulcers

Intervention

• 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.

• 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.

Study Arms

• 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.
  Intervention: Device: Compression Device
• 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.
  Intervention: Device: Profore

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 12, 2009): 90
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Ireland, United Kingdom

Administrative Information

• NCT Number: NCT00821431
• Other Study ID Numbers: CW-0500-05-U342
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: ConvaTec Inc.
• Study Sponsor: ConvaTec Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Jonathon Hopper, MD; ConvaTec Inc.

• PRS Account: ConvaTec Inc.
• Verification Date: January 2015