Clinical trial NCT00821431: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leg Ulcers
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Healing Measured by Number of Subjects Healed During the 12 Week Study Period
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Neuilly sur Seine
country: France
facility: Private Practice
city: Paris
country: France
facility: Groupe Hospitalier Saint-Joseph
city: Freiburg
country: Germany
facility: Hautarzt Phlebologe Allergologe
city: Gilching
country: Germany
facility: Private Practice
city: Hamburg
country: Germany
facility: Private Practice
city: Dublin
country: Ireland
facility: The Adelaide & Meath Hospital
city: Limerick
country: Ireland
facility: Mid-Western Regional Hospital
city: Wilton
country: Ireland
facility: Cork University Hospital
city: Airdrie
country: United Kingdom
facility: Dermatology Day Unit; Monklands Hospital
city: Alton
country: United Kingdom
facility: The Wilson Practice, Alton Health Centre
city: Cardiff
country: United Kingdom
facility: Wound Healing Research Unit; Cardiff University
city: Eastbourne
country: United Kingdom
facility: Tissue Viability Consultancy
city: Hull
country: United Kingdom
facility: Institute of Wound Care, The University of Hull
city: Plymouth
country: United Kingdom
facility: Diving Diseases Research Centre, Hyperbaric Medical Centre
city: Solihull
country: United Kingdom
facility: University Dept of Vascular
city: Southampton
country: United Kingdom
facility: Medical Physics & Bioengineering, Southampton University Hospital
city: Sutton Coldfield
country: United Kingdom
facility: Department of Vascular Surgery, Good Hope Hospital
city: Trowbridge
country: United Kingdom
facility: Trowbridge Community Hospital
city: Upton
country: United Kingdom
facility: Arrowe Park Hospital
city: Willenhall
country: United Kingdom
facility: Short Health Clinic
Study officials:
affiliation: ConvaTec Inc.
name: Jonathon Hopper, MD
role: STUDY_DIRECTOR
References: