Trial Outcomes & Findings for Intermittent Pneumatic Compression to Improve Revascularization Outcome (NCT NCT04250675)

NCT ID: NCT04250675

Last Updated: 2024-08-06

Results Overview

Change in 6 Minute Walk Test from baseline to 3 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Baseline and after 1 and 3 months of treatment
• Results posted on: 2024-08-06

Participant Flow

Participant milestones

Measure	Sham Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs. Sham: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.	Active Comparator - Intermittent Pneumatic Compression Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs. Intermittent pneumatic leg compressions: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.
Overall Study STARTED	5	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intermittent Pneumatic Compression to Improve Revascularization Outcome

Baseline characteristics by cohort

Measure	Sham n=5 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs. Sham: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.	Active Comparator - Intermittent Pneumatic Compression n=4 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs. Intermittent pneumatic leg compressions: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.	Total n=9 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
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	68 Years STANDARD_DEVIATION 8 • n=5 Participants	62 Years STANDARD_DEVIATION 6 • n=7 Participants	66 Years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 1 and 3 months of treatment

Change in 6 Minute Walk Test from baseline to 3 months

Outcome measures

Measure	Sham n=4 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs. Sham: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.	Active Comparator - Intermittent Pneumatic Compression n=4 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs. Intermittent pneumatic leg compressions: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.
Walking Endurance	-14 Meters Standard Deviation 25	35 Meters Standard Deviation 38

SECONDARY outcome

Timeframe: Baseline and after 3 months of treatment

Change in ABI from baseline to 3 months. A handheld 5-MHz Doppler ultrasound (Lumeon, McKesson) was used to obtain duplicate measurements of systolic pressures in the right posterior tibial artery, right dorsalis pedis artery, right brachial artery, left posterior tibial artery, left dorsalis pedis artery, and left brachial artery. The ABI of each leg was calculated by dividing the higher of the dorsalis pedis pressure or posterior tibial pressure by the higher of the right or left arm blood pressure

Outcome measures

Measure	Sham n=4 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs. Sham: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.	Active Comparator - Intermittent Pneumatic Compression n=4 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs. Intermittent pneumatic leg compressions: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.
Ankle-brachial Index (ABI)	0.04 AU Standard Deviation 0.07	-0.03 AU Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline and after 1 and 3 months treatment

Change in scores for VascuQol Questionnaire from baseline to 3 months. Overall score range is 7-175; higher score means higher quality of life.

Outcome measures

Measure	Sham n=4 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs. Sham: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.	Active Comparator - Intermittent Pneumatic Compression n=4 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs. Intermittent pneumatic leg compressions: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.
Vascular Quality of Life Score (VascuQol)	0.07 Units on a scale Standard Deviation 0.34	0.22 Units on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline and after 1 and 3 months of treatment

Change in toe-brachial index from baseline to 3 months. A toe-brachial index (TBI) is a non-invasive test that measures the ratio of systolic blood pressure in the toe to the higher systolic pressure in the arm. A toe/digit pressure cuff is wrapped around the measured toe, and a senso is placed on the toe distally to the pressure cuff.

Outcome measures

Measure	Sham n=4 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs. Sham: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.	Active Comparator - Intermittent Pneumatic Compression n=4 Participants Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs. Intermittent pneumatic leg compressions: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.
Toe-brachial Index	0.04 U Standard Deviation 0.19	-0.03 U Standard Deviation 0.07

Adverse Events

Sham

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Active Comparator - Intermittent Pneumatic Compression

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sham n=5 participants at risk Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs. Sham: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.	Active Comparator - Intermittent Pneumatic Compression n=4 participants at risk Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs. Intermittent pneumatic leg compressions: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.
Blood and lymphatic system disorders Hyperkalemia	0.00% 0/5 • 3 months	25.0% 1/4 • Number of events 1 • 3 months

Other adverse events

Measure	Sham n=5 participants at risk Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs. Sham: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.	Active Comparator - Intermittent Pneumatic Compression n=4 participants at risk Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs. Intermittent pneumatic leg compressions: Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.
Musculoskeletal and connective tissue disorders Leg discomfort during treatment	20.0% 1/5 • Number of events 1 • 3 months	0.00% 0/4 • 3 months

Additional Information

Bruno Roseguini

Purdue University

Phone: 7654906284

Email: brosegui@purdue.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place