Peripheral Arterial DiseaseNCT04250675
Intermittent Pneumatic Compression to Improve Revascularization Outcome
A study testing Intermittent pneumatic leg compressions in people with Peripheral Arterial Disease, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Intermittent pneumatic leg compressions
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Scheduled for endovascular revascularization of one or both lower extremities.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study
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.
Read the 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).
- Conditions
- Peripheral Arterial Disease
- Being tested
- Intermittent pneumatic leg compressions, Sham
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent pneumatic leg compressionsDevice
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.
ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | 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. Receives: Device: Sham |
| Active Comparator - Intermittent Pneumatic Compression | Active comparator | 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. Receives: Device: Intermittent pneumatic leg compressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Endurance
Change in 6 Minute Walk Test from baseline to 3 months
Measured: Baseline and after 1 and 3 months of treatment
Secondary outcomes (3)
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
Measured: Baseline and after 3 months of treatment
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.
Measured: Baseline and after 1 and 3 months treatment
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.
Measured: Baseline and after 1 and 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Roseguini, Bruno, PhD
- Responsible party
- Principal investigator, Raghu Motaganahalli, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250675
- Sponsor's protocol ID
- 1907961196
- Status last verified
- Aug 2024
- First submitted
- 15 Dec 2019
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT04250675
- Acronym / sponsor ID
- 1907961196
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Roseguini, Bruno, PhD
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: ShamParticipants 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. |
| Active Comparator - Intermittent Pneumatic Compression | Active comparator | Device: Intermittent pneumatic leg compressionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Scheduled for endovascular revascularization of one or both lower extremities.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent pneumatic leg compressionsPatients 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. | Device | Active Comparator - Intermittent Pneumatic Compression |
| ShamPatients 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. | Device | Sham |
Primary outcome
Walking Endurance
Time frame: Baseline and after 1 and 3 months of treatment
Change in 6 Minute Walk Test from baseline to 3 months
3 secondary outcomes
Ankle-brachial Index (ABI)
Time frame: Baseline and after 3 months of treatment
Vascular Quality of Life Score (VascuQol)
Time frame: Baseline and after 1 and 3 months treatment
Toe-brachial Index
Time frame: Baseline and after 1 and 3 months of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent pneumatic leg compressions in people with Peripheral Arterial Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Endurance (time frame: Baseline and after 1 and 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.