Trial Outcomes & Findings for Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs) (NCT NCT02395302)

Last Updated: 2017-03-27

Results Overview

A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below: 1. The device was comfortable to wear during Sustained Compression Mode. 2. The device was comfortable to wear during Intermittent Compression Mode. 3. The noise from the device was not bothersome. 4. The device was easy to put on. 5. The device was easy to take off. 6. The device was easy to use. 7. The device was light-weight and portable. 8. The use of the device helped my wound heal faster. 9. I would use the device again on another wound in the future. 10. Since using the device, my quality of sleep has improved. 11. It was a burden to come to the wound care clinic for my dressing changes. 12. The use of the device did not restrict many of my normal activities. 13. The device was cumbersome and interfered with my mobility. 14. I was able to work while being treated with the device.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Dual Action Pneumatic Compression Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet. Subjects that received the dual action pneumatic compression device were instructed to use the device in sustained mode for fourteen hours per day and in intermittent mode for three hours per day during the four week treatment period.
Overall Study STARTED	28
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Dual Action Pneumatic Compression Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet. Subjects that received the dual action pneumatic compression device were instructed to use the device in sustained mode for fourteen hours per day and in intermittent mode for three hours per day during the four week treatment period.
Overall Study Screen Failure	3
Overall Study Run In Failure	7
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	2

Baseline Characteristics

Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dual Action Pneumatic Compression n=27 Participants Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet. Dual Action Pneumatic Compression: Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.
Age, Continuous	61.9 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: The Tolerance and Comfort questionnaire was completed at study exit by 16 participants (13 of the 16 total subjects completed the study, 2 were withdrawn by their site's Investigator, and 1 voluntarily withdrew). Six participants were not employed during the time of questionnaire completion. Question 14 was not applicable to these participants.

Outcome measures

Outcome measures
Measure	Dual Action Pneumatic Compression n=16 Participants Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 1	12 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 2	8 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 3	9 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 4	15 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 5	15 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 6	15 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 7	11 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 8	8 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 9	13 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 10	7 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 11	6 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 12	9 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 13	9 Participants
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device Participants who agreed with Question 14	8 Participants

Adverse Events

Dual Action Pneumatic Compression

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dual Action Pneumatic Compression n=28 participants at risk Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
Injury, poisoning and procedural complications Pain in extremity	10.7% 3/28 • Number of events 4 • 6 weeks
Skin and subcutaneous tissue disorders Blister	10.7% 3/28 • Number of events 3 • 6 weeks
General disorders Migraine	3.6% 1/28 • Number of events 2 • 6 weeks
Injury, poisoning and procedural complications Skin ulcer	3.6% 1/28 • Number of events 1 • 6 weeks
Infections and infestations Wound infection	3.6% 1/28 • Number of events 1 • 6 weeks
Skin and subcutaneous tissue disorders Application site erythema	3.6% 1/28 • Number of events 1 • 6 weeks
Skin and subcutaneous tissue disorders Rash	3.6% 1/28 • Number of events 1 • 6 weeks
Infections and infestations Conjunctivitis infective	3.6% 1/28 • Number of events 1 • 6 weeks
Musculoskeletal and connective tissue disorders Cramping	3.6% 1/28 • Number of events 1 • 6 weeks

Additional Information

Clinical Research Manager

Tactile Medical

Phone: (612)355-5123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60