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Compression Device Versus 4-layer Compression System

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ClinicalTrials.gov Identifier: NCT00821431
Recruitment Status : Completed
First Posted : January 13, 2009
Results First Posted : January 9, 2015
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.

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
Hide 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
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 52 participants 90 participants
60.9  (16.72) 62.6  (15.41) 61.89  (15.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 52 participants 90 participants
Female
21
  55.3%
23
  44.2%
44
  48.9%
Male
17
  44.7%
29
  55.8%
46
  51.1%
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
1.Primary Outcome
Title Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)
Hide Description [Not Specified]
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Compression Device Profore, 4-layer Bandage
Hide 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.

Overall Number of Participants Analyzed 38 52
Measure Type: Number
Unit of Measure: Number of Subjects with Adverse Events
33 47
2.Secondary Outcome
Title Healing Measured by Number of Subjects Healed During the 12 Week Study Period
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Compression Device Profore, 4-layer Bandage
Hide 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.

Overall Number of Participants Analyzed 38 52
Measure Type: Number
Unit of Measure: Number of subjects healed
12 22
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Compression Device Profore, 4-layer Bandage
Hide 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.

All-Cause Mortality
Compression Device Profore, 4-layer Bandage
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Compression Device Profore, 4-layer Bandage
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      3/52 (5.77%)    
Blood and lymphatic system disorders     
Deep vein thrombosis  0/38 (0.00%)  0 1/52 (1.92%)  1
Skin and subcutaneous tissue disorders     
Blisters/ulcer/skin breakdown/weepy under wfr/dsg  0/38 (0.00%)  0 1/52 (1.92%)  1
Surgical and medical procedures     
Prostatic Procedures  0/38 (0.00%)  0 1/52 (1.92%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Compression Device Profore, 4-layer Bandage
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/38 (86.84%)      47/52 (90.38%)    
Blood and lymphatic system disorders     
Oedema  6/38 (15.79%)  3/52 (5.77%) 
Increase in drainage/exudate  5/38 (13.16%)  7/52 (13.46%) 
General disorders     
Headache  2/38 (5.26%)  0/52 (0.00%) 
Infections and infestations     
Infection, Non-Study Location  5/38 (13.16%)  1/52 (1.92%) 
Infection, Study Location  5/38 (13.16%)  9/52 (17.31%) 
Cellulitis  0/38 (0.00%)  3/52 (5.77%) 
Skin and subcutaneous tissue disorders     
Maceration  18/38 (47.37%)  13/52 (25.00%) 
Pain attributed to wound  12/38 (31.58%)  11/52 (21.15%) 
Erythema  11/38 (28.95%)  17/52 (32.69%) 
Eczema/worsening  7/38 (18.42%)  19/52 (36.54%) 
Blisters/ulcer/skin breakdown/weepy under wfr/dsg  6/38 (15.79%)  7/52 (13.46%) 
Dry/Flaky skin under device  6/38 (15.79%)  9/52 (17.31%) 
Wound enlarged/deteriorated  3/38 (7.89%)  7/52 (13.46%) 
Necrotic or sloughy wound  2/38 (5.26%)  1/52 (1.92%) 
Hypergranulation  2/38 (5.26%)  4/52 (7.69%) 
Chafing under device  2/38 (5.26%)  2/52 (3.85%) 
Blstrs/ulcr/skin brkdwn/weepy-diff.location  2/38 (5.26%)  0/52 (0.00%) 
Pain/discomf at ankle, study leg  2/38 (5.26%)  4/52 (7.69%) 
Pain/discomf at shin, study leg  2/38 (5.26%)  1/52 (1.92%) 
Pain/discomf at ankle w/irrit, study leg  2/38 (5.26%)  0/52 (0.00%) 
Vascular disorders     
Pain lower leg  4/38 (10.53%)  9/52 (17.31%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kim Peters, Director of Clinical Affairs
Organization: ConvaTec
Phone: 07889841338
EMail: kim.peters@convatec.com
Layout table for additonal information
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