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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

Tracking Information
First Submitted Date  ICMJE December 15, 2019
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
Walking endurance [ Time Frame: Baseline and after 1 and 3 months of treatment ]
Change in maximal treadmill walking time from baseline to 3 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • Ankle-brachial index (ABI) [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in ABI from baseline to 3 months
  • Toe-brachial index (TBI) [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in TBI from baseline to 3 months
  • 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
  • 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.
  • 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
  • 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
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • Ankle-brachial index (ABI) [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in ABI from baseline to 3 months
  • Toe-brachial index (TBI) [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in TBI from baseline to 3 months
  • Transcutaneous PO2 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
  • Rest leg pain - VAS [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in VAS Pain Scale Ruler score from baseline to 3 months
  • Calf muscle oxygenation [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in peak calf muscle oxygenation from baseline to 3 months
  • Leg circumference [ Time Frame: Baseline and after 1 and 3 months of treatment ]
    Change in leg circumference from baseline to 3 months
  • 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
  • Quality of Life Score - SF-36 [ Time Frame: Baseline and after 1 and 3 months treatment ]
    Change in scores for SF-36 Questionnaire from baseline to 3 months
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intermittent Pneumatic Compression to Improve Revascularization Outcome
Official Title  ICMJE Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Sham
  • 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.
    Intervention: Device: Intermittent pneumatic leg compressions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bruno Roseguni, PhD 765-496-2612 brosegui@purdue.edu
Contact: Janet Klein, RN, MSN 317-962-0287 jswklein@iupui.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250675
Other Study ID Numbers  ICMJE 1907961196
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raghu Motaganahalli, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Bruno Roseguini, PhD
Investigators  ICMJE Not Provided
PRS Account Indiana University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP