Trial Outcomes & Findings for Compression Device Versus 4-layer Compression System (NCT NCT00821431)
NCT ID: NCT00821431
Last Updated: 2015-01-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
12 Weeks
Results posted on
2015-01-09
Participant Flow
Participant milestones
| Measure |
Compression Device
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.
|
Profore, 4-layer Bandage
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 Study
STARTED
|
38
|
52
|
|
Overall Study
COMPLETED
|
23
|
47
|
|
Overall Study
NOT COMPLETED
|
15
|
5
|
Reasons for withdrawal
| Measure |
Compression Device
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.
|
Profore, 4-layer Bandage
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 Study
Adverse Event
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Compression Device Versus 4-layer Compression System
Baseline characteristics by cohort
| Measure |
Compression Device
n=38 Participants
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.
|
Profore, 4-layer Bandage
n=52 Participants
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
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 16.72 • n=93 Participants
|
62.6 years
STANDARD_DEVIATION 15.41 • n=4 Participants
|
61.89 years
STANDARD_DEVIATION 15.90 • n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
1 participants
n=93 Participants
|
5 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Region of Enrollment
Ireland
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=93 Participants
|
12 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
23 participants
n=93 Participants
|
30 participants
n=4 Participants
|
53 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksOutcome measures
| Measure |
Compression Device
n=38 Participants
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.
|
Profore, 4-layer Bandage
n=52 Participants
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.
|
|---|---|---|
|
Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)
|
33 Number of Subjects with Adverse Events
|
47 Number of Subjects with Adverse Events
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Compression Device
n=38 Participants
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.
|
Profore, 4-layer Bandage
n=52 Participants
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.
|
|---|---|---|
|
Healing Measured by Number of Subjects Healed During the 12 Week Study Period
|
12 Number of subjects healed
|
22 Number of subjects healed
|
Adverse Events
Compression Device
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Profore, 4-layer Bandage
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Compression Device
n=38 participants at risk
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.
|
Profore, 4-layer Bandage
n=52 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Blisters/ulcer/skin breakdown/weepy under wfr/dsg
|
0.00%
0/38
|
1.9%
1/52 • Number of events 1
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
0.00%
0/38
|
1.9%
1/52 • Number of events 1
|
|
Surgical and medical procedures
Prostatic Procedures
|
0.00%
0/38
|
1.9%
1/52 • Number of events 1
|
Other adverse events
| Measure |
Compression Device
n=38 participants at risk
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.
|
Profore, 4-layer Bandage
n=52 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Maceration
|
47.4%
18/38
|
25.0%
13/52
|
|
Skin and subcutaneous tissue disorders
Pain attributed to wound
|
31.6%
12/38
|
21.2%
11/52
|
|
Skin and subcutaneous tissue disorders
Erythema
|
28.9%
11/38
|
32.7%
17/52
|
|
Skin and subcutaneous tissue disorders
Eczema/worsening
|
18.4%
7/38
|
36.5%
19/52
|
|
Skin and subcutaneous tissue disorders
Blisters/ulcer/skin breakdown/weepy under wfr/dsg
|
15.8%
6/38
|
13.5%
7/52
|
|
Blood and lymphatic system disorders
Oedema
|
15.8%
6/38
|
5.8%
3/52
|
|
Skin and subcutaneous tissue disorders
Dry/Flaky skin under device
|
15.8%
6/38
|
17.3%
9/52
|
|
Infections and infestations
Infection, Non-Study Location
|
13.2%
5/38
|
1.9%
1/52
|
|
Infections and infestations
Infection, Study Location
|
13.2%
5/38
|
17.3%
9/52
|
|
Blood and lymphatic system disorders
Increase in drainage/exudate
|
13.2%
5/38
|
13.5%
7/52
|
|
Vascular disorders
Pain lower leg
|
10.5%
4/38
|
17.3%
9/52
|
|
Skin and subcutaneous tissue disorders
Wound enlarged/deteriorated
|
7.9%
3/38
|
13.5%
7/52
|
|
Skin and subcutaneous tissue disorders
Necrotic or sloughy wound
|
5.3%
2/38
|
1.9%
1/52
|
|
Skin and subcutaneous tissue disorders
Hypergranulation
|
5.3%
2/38
|
7.7%
4/52
|
|
Skin and subcutaneous tissue disorders
Chafing under device
|
5.3%
2/38
|
3.8%
2/52
|
|
Skin and subcutaneous tissue disorders
Blstrs/ulcr/skin brkdwn/weepy-diff.location
|
5.3%
2/38
|
0.00%
0/52
|
|
Skin and subcutaneous tissue disorders
Pain/discomf at ankle, study leg
|
5.3%
2/38
|
7.7%
4/52
|
|
Skin and subcutaneous tissue disorders
Pain/discomf at shin, study leg
|
5.3%
2/38
|
1.9%
1/52
|
|
Skin and subcutaneous tissue disorders
Pain/discomf at ankle w/irrit, study leg
|
5.3%
2/38
|
0.00%
0/52
|
|
General disorders
Headache
|
5.3%
2/38
|
0.00%
0/52
|
|
Infections and infestations
Cellulitis
|
0.00%
0/38
|
5.8%
3/52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place