Compression Device Versus 4-layer Compression System

Phase 2

Completed

Conditions: Leg Ulcers

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

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

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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
The Adelaide & Meath Hospital
🇮🇪
Dublin, Ireland
Mid-Western Regional Hospital
🇮🇪
Limerick, Ireland
Cork University Hospital
🇮🇪
Wilton, Ireland
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
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Private Practice
🇩🇪Hamburg, Germany