Compression Device Versus 4-layer Compression System

Leg Ulcers Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821431
• Other study ID #: CW-0500-05-U342
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2009
• Last updated: January 8, 2015
• Start date: May 2006
• Est. completion date: June 2008

Study information

• Verified date: January 2015
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIreland: Irish Medicines BoardFrance: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• 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.
• 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.

Locations

Country	Name	City	State
France	Private Practice	Neuilly sur Seine
France	Groupe Hospitalier Saint-Joseph	Paris
Germany	Hautarzt Phlebologe Allergologe	Freiburg
Germany	Private Practice	Gilching
Germany	Private Practice	Hamburg
Ireland	The Adelaide & Meath Hospital	Dublin
Ireland	Mid-Western Regional Hospital	Limerick
Ireland	Cork University Hospital	Wilton
United Kingdom	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	Institute of Wound Care, The University of Hull	Hull
United Kingdom	Diving Diseases Research Centre, Hyperbaric Medical Centre	Plymouth
United Kingdom	University Dept of Vascular	Solihull
United Kingdom	Medical Physics & Bioengineering, Southampton University Hospital	Southampton
United Kingdom	Department of Vascular Surgery, Good Hope Hospital	Sutton Coldfield
United Kingdom	Trowbridge Community Hospital	Trowbridge
United Kingdom	Arrowe Park Hospital	Upton
United Kingdom	Short Health Clinic	Willenhall

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Countries where clinical trial is conducted

France,  Germany,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)		12 Weeks	No
Secondary	Healing Measured by Number of Subjects Healed During the 12 Week Study Period		12 weeks	No