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Intermittent Pneumatic Compression to Improve Revascularization Outcome

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ClinicalTrials.gov Identifier: NCT04250675
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Bruno Roseguini, PhD
Information provided by (Responsible Party):
Raghu Motaganahalli, Indiana University

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Intermittent pneumatic leg compressions Device: Sham Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: 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.
Device: 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: 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.
Device: 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.




Primary Outcome Measures :
  1. Walking endurance [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in maximal treadmill walking time from baseline to 3 months


Secondary Outcome Measures :
  1. Ankle-brachial index (ABI) [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in ABI from baseline to 3 months

  2. Toe-brachial index (TBI) [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in TBI from baseline to 3 months

  3. Transcutaneous Oxygen Pressure at the dorsum of the foot (TcPO2) [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in TcPO2 from baseline to 3 months

  4. Rest leg pain [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in Visual Analog Scale Pain Scale Ruler score (0-100) from baseline to 3 months. 0mm=no pain, 100mm=extreme pain.

  5. Calf muscle deoxygenated hemoglobin concentration [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in calf muscle deoxygenated hemoglobin concentration from baseline to 3 months

  6. Calf circumference [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in calf circumference tape measure measurement from baseline to 3 months

  7. Vascular Quality of Life Score (VascuQol) [ Time Frame: 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.

  8. Quality of Life Score - Short Form-36 [ Time Frame: Baseline and after 1 and 3 months treatment ]
    Change in scores for Short Form-36 Questionnaire from baseline to 3 months. Eight health concepts scored 0-100 range. High score is a more favorable health state.

  9. Blood level marker of coagulation - D-Dimer [ Time Frame: Baseline and after 1 and 3 months treatment ]
    Change in D-Dimer levels from baseline to 3 months

  10. Blood level marker of coagulation - PT/INR [ Time Frame: Baseline and after 1 and 3 months treatment ]
    Change in PT/INR level from baseline to 3 months

  11. Blood level marker of coagulation - thrombin time [ Time Frame: Baseline and after 1 and 3 months treatment ]
    Change in thrombin levels from baseline to 3 months

  12. Blood level marker of fibrinolysis - fibrinogen [ Time Frame: Baseline and after 1 and 3 months treatment ]
    Change in fibrinogen levels from baseline to 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound or MR imaging.
  • 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
  • Inability to walk on the treadmill
  • Abnormal baseline treadmill stress test
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250675


Contacts
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Contact: Bruno Roseguni, PhD 765-496-2612 brosegui@purdue.edu
Contact: Janet Klein, RN, MSN 317-962-0287 jswklein@iupui.edu

Locations
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United States, Indiana
IU Health Methodist Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Janet Klein, RN, MSN    317-962-0287    jswklein@iupui.edu   
Sponsors and Collaborators
Indiana University
Bruno Roseguini, PhD
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Responsible Party: Raghu Motaganahalli, Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT04250675    
Other Study ID Numbers: 1907961196
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases