Peripheral Arterial Disease
Conditions
Brief summary
The purpose of this study is to investigate whether daily treatment with intermittent pneumatic leg compressions (IPC) following a nonsurgical vascular procedure improves circulation and enhances walking distance.
Detailed description
Restenosis following revascularization procedures occur frequently and as early as 3 months after the intervention. There is an urgent need for adjunctive therapies that aid in the improvement of tissue blood flow and consequently relieve pain and improve functional capacity in these patients. It has been previously shown that exposure to IPC enhances leg blood flow to collateral-dependent tissues. In this study, subjects who have undergone nonsurgical revascularization will be randomly assigned to two groups: IPC or placebo pump. Subjects will receive a commercially available IPC device (Art Assist, ACI Medical, San Marcos, CA) and will apply the treatment at home for 2 hours daily over 3 consecutive months. At 3 time points (pre, 1 and 3 months post procedure) assessments will be performed (hemodynamics, rest pain, calf muscle oxygenation during exercise, walking endurance and quality of life).
Interventions
DEVICEIntermittent 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.
DEVICESham
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.
Sponsors
Roseguini, Bruno, PhD
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Scheduled for endovascular revascularization of one or both lower extremities.
Exclusion criteria
* Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula) * Open and/or non-healing wounds in the areas covered by IPC cuff * Walking limited by a symptom other than PAD * Presence of any clinical condition that makes the patient unsuitable to participate in the trial * Concern for inability of the patient to comply with study procedures and/or follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Endurance | Baseline and after 1 and 3 months of treatment | Change in 6 Minute Walk Test from baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle-brachial Index (ABI) | 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 |
| Vascular Quality of Life Score (VascuQol) | 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. |
| Toe-brachial Index | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Active Comparator - Intermittent Pneumatic Compression | Total | Sham |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Continuous | 62 Years STANDARD_DEVIATION 6 | 66 Years STANDARD_DEVIATION 8 | 68 Years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment United States | 4 participants | 9 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 1 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 1 / 4 |
Outcome results
Primary
Walking Endurance
Change in 6 Minute Walk Test from baseline to 3 months
Time frame: Baseline and after 1 and 3 months of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham | Walking Endurance | -14 Meters | Standard Deviation 25 |
| Active Comparator - Intermittent Pneumatic Compression | Walking Endurance | 35 Meters | Standard Deviation 38 |
Secondary
Ankle-brachial Index (ABI)
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
Time frame: Baseline and after 3 months of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham | Ankle-brachial Index (ABI) | 0.04 AU | Standard Deviation 0.07 |
| Active Comparator - Intermittent Pneumatic Compression | Ankle-brachial Index (ABI) | -0.03 AU | Standard Deviation 0.07 |
Secondary
Toe-brachial Index
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.
Time frame: Baseline and after 1 and 3 months of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham | Toe-brachial Index | 0.04 U | Standard Deviation 0.19 |
| Active Comparator - Intermittent Pneumatic Compression | Toe-brachial Index | -0.03 U | Standard Deviation 0.07 |
Secondary
Vascular Quality of Life Score (VascuQol)
Change in scores for VascuQol Questionnaire from baseline to 3 months. Overall score range is 7-175; higher score means higher quality of life.
Time frame: Baseline and after 1 and 3 months treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham | Vascular Quality of Life Score (VascuQol) | 0.07 Units on a scale | Standard Deviation 0.34 |
| Active Comparator - Intermittent Pneumatic Compression | Vascular Quality of Life Score (VascuQol) | 0.22 Units on a scale | Standard Deviation 0.67 |