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Sponsored by: |
ConvaTec Inc. |
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Information provided by: | ConvaTec Inc. |
ClinicalTrials.gov Identifier: | NCT00821431 |
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.
Condition | Intervention | Phase |
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Leg Ulcers |
Device: Compression Device Device: Profore |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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. |
Enrollment: | 90 |
Study Start Date: | May 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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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 pressurs: 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, 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.
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Device: 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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects who had leg sizes outside the following range:
Amendment #1 dated 27th March 2007:
Amendment #2 dated 2nd August 2007:
Amendment #3 dated 5th October 2007:
France | |
Private Practice | |
Neuilly sur Seine, France | |
Groupe Hospitalier Saint-Joseph | |
Paris, France | |
Germany | |
Hautarzt Phlebologe Allergologe | |
Freiburg, Germany | |
Private Practice | |
Hamburg, Germany | |
Private Practice | |
Gilching, Germany | |
Ireland | |
Cork University Hospital | |
Wilton, Ireland | |
Mid-Western Regional Hospital | |
Limerick, Ireland | |
The Adelaide & Meath Hospital | |
Dublin, Ireland | |
United Kingdom | |
Wound Healing Research Unit; Cardiff University | |
Cardiff, United Kingdom | |
Dermatology Day Unit; Monklands Hospital | |
Airdrie, United Kingdom | |
The Wilson Practice, Alton Health Centre | |
Alton, United Kingdom | |
Arrowe Park Hospital | |
Upton, United Kingdom | |
Medical Physics & Bioengineering, Southampton University Hospital | |
Southampton, United Kingdom | |
Diving Diseases Research Centre, Hyperbaric Medical Centre | |
Plymouth, United Kingdom | |
Institute of Wound Care, The University of Hull | |
Hull, United Kingdom | |
Department of Vascular Surgery, Good Hope Hospital | |
Sutton Coldfield, United Kingdom | |
Tissue Viability Consultancy | |
Eastbourne, United Kingdom | |
University Dept of Vascular | |
Solihull, United Kingdom | |
Short Health Clinic | |
Willenhall, United Kingdom | |
Trowbridge Community Hospital | |
Trowbridge, United Kingdom |
Study Director: | Jonathon Hopper, MD | ConvaTec Inc. |
Responsible Party: | ConvaTec Inc. ( Dheerendra Kommala, MD ) |
Study ID Numbers: | CW-0500-05-U342 |
Study First Received: | January 9, 2009 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00821431 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board; France: Ministry of Health |
Skin Diseases Ulcer Skin Ulcer Leg Ulcer |
Pathologic Processes Skin Diseases Ulcer Skin Ulcer Leg Ulcer |