NCT00821431

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Geographic Reach
4 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
6 years until next milestone

Results Posted

Study results publicly available

January 9, 2015

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.1 years

First QC Date

January 9, 2009

Results QC Date

September 3, 2014

Last Update Submit

January 8, 2015

Conditions

Leg Ulcers

Outcome Measures

Primary Outcomes (1)

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

    12 Weeks

Secondary Outcomes (1)

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

    12 weeks

Study Arms (2)

Compression device

EXPERIMENTAL

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

Profore, 4-layer bandage

ACTIVE COMPARATOR

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

Interventions

Compression DeviceDEVICE

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.

Compression device
ProforeDEVICE

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.

Profore, 4-layer bandage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Private Practice

Neuilly-sur-Seine, France

Location

Groupe Hospitalier Saint-Joseph

Paris, France

Location

Hautarzt Phlebologe Allergologe

Freiburg im Breisgau, Germany

Location

Private Practice

Gilching, Germany

Location

Private Practice

Hamburg, Germany

Location

The Adelaide & Meath Hospital

Dublin, Ireland

Location

Mid-Western Regional Hospital

Limerick, Ireland

Location

Cork University Hospital

Wilton, Ireland

Location

Dermatology Day Unit; Monklands Hospital

Airdrie, United Kingdom

Location

The Wilson Practice, Alton Health Centre

Alton, United Kingdom

Location

Wound Healing Research Unit; Cardiff University

Cardiff, United Kingdom

Location

Tissue Viability Consultancy

Eastbourne, United Kingdom

Location

Institute of Wound Care, The University of Hull

Hull, United Kingdom

Location

Diving Diseases Research Centre, Hyperbaric Medical Centre

Plymouth, United Kingdom

Location

University Dept of Vascular

Solihull, United Kingdom

Location

Medical Physics & Bioengineering, Southampton University Hospital

Southampton, United Kingdom

Location

Department of Vascular Surgery, Good Hope Hospital

Sutton Coldfield, United Kingdom

Location

Trowbridge Community Hospital

Trowbridge, United Kingdom

Location

Arrowe Park Hospital

Upton, United Kingdom

Location

Short Health Clinic

Willenhall, United Kingdom

Location

MeSH Terms

Conditions

Leg Ulcer

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

Title
Kim Peters, Director of Clinical Affairs
Organization
ConvaTec
kim.peters@convatec.com
07889841338

Study Officials

  • Jonathon Hopper, MD

    ConvaTec Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 13, 2009

Study Start

May 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 9, 2015

Results First Posted

January 9, 2015

Record last verified: 2015-01

Locations

DE(3)GB(12)FR(2)IE(3)