Trial Outcomes & Findings for Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort (NCT NCT02015221)
NCT ID: NCT02015221
Last Updated: 2016-12-15
Results Overview
Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
30 days
Results posted on
2016-12-15
Participant Flow
Participant milestones
| Measure |
ACTitouch
ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
|
Standard Compression Garments
Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
|
Overall Study
COMPLETED
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
ACTitouch
ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
|
Standard Compression Garments
Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
Baseline characteristics by cohort
| Measure |
ACTitouch
n=41 Participants
ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
|
Standard Compression Garments
n=40 Participants
Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
40 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysEase of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.
Outcome measures
| Measure |
ACTitouch
n=66 Lower Extremities Analyzed
ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
|
Standard Compression Garments
n=70 Lower Extremities Analyzed
Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression.
|
|---|---|---|
|
Ease of Use and Comfort for Subjects Using the ACTitouch System.
% Reported Easy/Very EasyDoffing - Baseline
|
89.2 Percent of participants
Interval 79.4 to 94.7
|
59.4 Percent of participants
Interval 47.1 to 70.5
|
|
Ease of Use and Comfort for Subjects Using the ACTitouch System.
% Reported Comfortable/Very 1st Applied - Baseline
|
70.8 Percent of participants
Interval 58.8 to 80.4
|
57.8 Percent of participants
Interval 45.6 to 69.1
|
|
Ease of Use and Comfort for Subjects Using the ACTitouch System.
% Reported Easy/Very Easy Donning - 30 Days
|
64.9 Percent of participants
Interval 51.9 to 76.0
|
54.8 Percent of participants
Interval 42.5 to 66.6
|
|
Ease of Use and Comfort for Subjects Using the ACTitouch System.
% Reported Easy/Very Easy Doffing - 30 Day
|
89.5 Percent of participants
Interval 78.9 to 95.1
|
66.1 Percent of participants
Interval 53.7 to 76.7
|
|
Ease of Use and Comfort for Subjects Using the ACTitouch System.
% Reported Comfortable/Very 1st Applied - 30 Days
|
54.4 Percent of participants
Interval 41.6 to 66.6
|
63.9 Percent of participants
Interval 51.4 to 74.8
|
|
Ease of Use and Comfort for Subjects Using the ACTitouch System.
% Reported Comfortable/Very IPC 30 days
|
62.3 Percent of participants
Interval 48.8 to 74.1
|
0 Percent of participants
Interval 0.0 to 0.0
|
|
Ease of Use and Comfort for Subjects Using the ACTitouch System.
% Reported Easy/Very Easy Donning - Baseline
|
70.8 Percent of participants
Interval 58.8 to 80.4
|
37.5 Percent of participants
Interval 26.7 to 49.7
|
Adverse Events
ACTitouch
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard Compression Garments
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACTitouch
n=41 participants at risk
ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
|
Standard Compression Garments
n=40 participants at risk
Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ulcer / Blister
|
7.3%
3/41 • Number of events 3 • 30 days
|
0.00%
0/40 • 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/41 • Number of events 1 • 30 days
|
0.00%
0/40 • 30 days
|
|
Vascular disorders
Swelling
|
2.4%
1/41 • Number of events 1 • 30 days
|
0.00%
0/40 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60