Trial Outcomes & Findings for Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema (NCT NCT02284373)
NCT ID: NCT02284373
Last Updated: 2020-03-13
Results Overview
Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
30 days
Results posted on
2020-03-13
Participant Flow
Participant milestones
| Measure |
Randomization Arm 1:
70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded
Flexitouch for 1 month in addition to routine wound care: simultaneous wound care and pneumonic compression
|
Randomization Arm 2:
70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Routine wound care for venous ulcers and lymphedema: wound care /dressings
|
Observational Arm 3
50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.
Flexitouch pneumonic compression: pneumonic compression only
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
29
|
|
Overall Study
COMPLETED
|
5
|
2
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Randomization Arm 1:
70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded
Flexitouch for 1 month in addition to routine wound care: simultaneous wound care and pneumonic compression
|
Randomization Arm 2:
70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Routine wound care for venous ulcers and lymphedema: wound care /dressings
|
Observational Arm 3
50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.
Flexitouch pneumonic compression: pneumonic compression only
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
Baseline characteristics by cohort
| Measure |
Randomization Arm 1:
n=5 Participants
70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded
Flexitouch for 1 month in addition to routine wound care: simultaneous wound care and pneumonic compression
|
Randomization Arm 2:
n=2 Participants
70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Routine wound care for venous ulcers and lymphedema: wound care /dressings
|
Observational Arm 3
n=29 Participants
50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.
Flexitouch pneumonic compression: pneumonic compression only
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
29 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Randomization Arm 1:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Randomization Arm 2:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Observational Arm 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Todd Berland, MD
New York University Langone Medical Center
Phone: 212 263 5060
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place