Completed

NCT Number: NCT00821431

Compression Device Versus 4-layer Compression System

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.

Completed

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Key information

Conditions

Leg Ulcers Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Private Practice, Neuilly-sur-Seine, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compression device

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.

Profore

Device

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 outcomes

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

Time frame: 12 Weeks

Secondary outcomes

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

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study 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.

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jan 13, 2009
Registry last updated: Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed