Compression Device Versus 4-layer Compression System
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| ClinicalTrials.gov Identifier: NCT00821431 |
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Recruitment Status :
Completed
First Posted : January 13, 2009
Results First Posted : January 9, 2015
Last Update Posted : January 9, 2015
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Leg Ulcers |
| Interventions |
Device: Compression Device Device: Profore |
| Enrollment | 90 |
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Compression Device | Profore, 4-layer Bandage |
|---|---|---|
 Arm/Group Description |
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. 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. |
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. 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. |
| Period Title: Overall Study | ||
| Started | 38 | 52 |
| Completed | 23 | 47 |
| Not Completed | 15 | 5 |
| Reason Not Completed | ||
| Adverse Event | 6 | 3 |
| Withdrawal by Subject | 5 | 0 |
| Lost to Follow-up | 1 | 0 |
| Protocol Violation | 3 | 1 |
| Physician Decision | 0 | 1 |
| Arm/Group Title | Compression Device | Profore, 4-layer Bandage | Total | |
|---|---|---|---|---|
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Arm/Group Description |
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. 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. |
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. 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. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 38 | 52 | 90 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 38 participants | 52 participants | 90 participants | |
| 60.9 (16.72) | 62.6 (15.41) | 61.89 (15.90) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 38 participants | 52 participants | 90 participants | |
| Female |
21 55.3%
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23 44.2%
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44 48.9%
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| Male |
17 44.7%
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29 55.8%
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46 51.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 38 participants | 52 participants | 90 participants |
| France | 1 | 5 | 6 | |
| Ireland | 5 | 5 | 10 | |
| Germany | 9 | 12 | 21 | |
| United Kingdom | 23 | 30 | 53 | |
| Name/Title: | Kim Peters, Director of Clinical Affairs |
| Organization: | ConvaTec |
| Phone: | 07889841338 |
| EMail: | kim.peters@convatec.com |
| Responsible Party: | ConvaTec Inc. |
| ClinicalTrials.gov Identifier: | NCT00821431 |
| Other Study ID Numbers: |
CW-0500-05-U342 |
| First Submitted: | January 9, 2009 |
| First Posted: | January 13, 2009 |
| Results First Submitted: | September 3, 2014 |
| Results First Posted: | January 9, 2015 |
| Last Update Posted: | January 9, 2015 |