Trial Outcomes & Findings for Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE) (NCT NCT03465735)
NCT ID: NCT03465735
Last Updated: 2020-08-12
Results Overview
Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
baseline, 10 days
Results posted on
2020-08-12
Participant Flow
Participant milestones
| Measure |
Standard of Care
Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present.
Standard of Care: Anticoagulant therapy will be decided by physician and patient.
|
Vascular Boot Group
For each vascular boot session, the following data will be recorded:
Wearing the vascular boot during first 10 days of study for minimum of 30 minutes per day
Vascular Boot: The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.
Standard of Care: Anticoagulant therapy will be decided by physician and patient.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=8 Participants
Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present.
Standard of Care: Anticoagulant therapy will be decided by physician and patient.
|
Vascular Boot Group
n=7 Participants
For each vascular boot session, the following data will be recorded:
Wearing the vascular boot during first 10 days of study for minimum of 30 minutes per day
Vascular Boot: The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.
Standard of Care: Anticoagulant therapy will be decided by physician and patient.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 17.5 • n=8 Participants
|
66.4 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 16.6 • n=15 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
7 participants
n=7 Participants
|
15 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: baseline, 10 daysPopulation: Study terminated due to lack of recruitment of eligible participants. Data was not analyzed due to lack of recruitment. Data not analyzed and no longer available to be analyzed.
Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Vascular Boot Group
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 |
Standard of Care
n=8 participants at risk
Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present.
Standard of Care: Anticoagulant therapy will be decided by physician and patient.
|
Vascular Boot Group
n=7 participants at risk
For each vascular boot session, the following data will be recorded:
Wearing the vascular boot during first 10 days of study for minimum of 30 minutes per day
Vascular Boot: The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.
Standard of Care: Anticoagulant therapy will be decided by physician and patient.
|
|---|---|---|
|
Cardiac disorders
Occlusive thrombi
|
12.5%
1/8 • Number of events 1 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
0.00%
0/7 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
|
Musculoskeletal and connective tissue disorders
Thoracic Back Pain
|
12.5%
1/8 • Number of events 1 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
0.00%
0/7 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
|
Cardiac disorders
Chest Pain
|
12.5%
1/8 • Number of events 1 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
0.00%
0/7 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
|
Injury, poisoning and procedural complications
Chemical Exposure
|
12.5%
1/8 • Number of events 1 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
0.00%
0/7 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
|
Renal and urinary disorders
Dysuria
|
12.5%
1/8 • Number of events 1 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
0.00%
0/7 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8 • Number of events 1 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
0.00%
0/7 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
|
Renal and urinary disorders
Left adnexal cyst
|
12.5%
1/8 • Number of events 1 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
0.00%
0/7 • Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place