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Trial record 11 of 13 for:    VM202

Hepatocyte Growth Factor to Improve Functioning in PAD (HI-PAD)

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ClinicalTrials.gov Identifier: NCT03363165
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Helixmith Co., Ltd.
Information provided by (Responsible Party):
Mary McDermott, Northwestern University

Tracking Information
First Submitted Date  ICMJE November 30, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
Six-minute walk distance [ Time Frame: Change from baseline to three-month follow-up in six-minute walk distance ]
Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
Six-minute walk performance [ Time Frame: Change from baseline to three-month follow-up ]
Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
Change History Complete list of historical versions of study NCT03363165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Maximal and pain-free treadmill walking time [ Time Frame: Change from baseline to three-month follow-up ]
    A Gardner or Modified Gardner treadmill exercise protocol will be used
  • Calf muscle perfusion [ Time Frame: Change from baseline to three-month follow-up ]
    Calf muscle perfusion is measured by magnetic resonance imaging (MRI)
  • Calf muscle biopsy biochemical measures [ Time Frame: Change from baseline to three-month follow-up ]
    A skeletal muscle sample will be obtained from the calf muscle.
  • Walking Impairment Questionnaire [ Time Frame: Change from baseline to three-month follow-up ]
    The well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance. The WIQ is scored from 0-100, with 100 being the best score. We will use distance and speed sub-components separately.
  • The Short-Form-36 Physical Functioning Score [ Time Frame: Change from baseline to three-month follow-up ]
    This well validated quality of life measure will be used to assess changes in patient perceived quality of life. The SF-36 is scored from 0-100, with 100 being the best score.
  • The Short-Form-36 Physical Functioning Score [ Time Frame: Change from baseline to six-month follow-up ]
    This well validated quality of life measure will be used to assess changes in patient perceived quality of life.
  • Walking Impairment Questionnaire [ Time Frame: Change from baseline to six-month follow-up ]
    The well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance.
  • Six-minute walk distance [ Time Frame: Change in six-minute walk distance from baseline to six-month follow-up ]
    Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
  • Six-minute walk distance [ Time Frame: Change from baseline to 12-month follow-up in six minute walk distance ]
    See above regarding 6-minute walk protocol.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
  • Maximal and pain-free treadmill walking time [ Time Frame: Change from baseline to three-month follow-up ]
    A Gardner or Modified Gardner treadmill exercise protocol will be used
  • Increase in calf muscle perfusion [ Time Frame: Change from baseline to three-month follow-up ]
    Calf muscle perfusion is measured by magnetic resonance imaging (MRI)
  • Calf muscle biopsy biochemical measures [ Time Frame: Change from baseline to three-month follow-up ]
    A skeletal muscle sample will be obtained from the gastrocnemius muscle.
  • Walking Impairment Questionnaire [ Time Frame: Change from baseline to three-month follow-up ]
    The well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance.
  • The Short-Form-36 Physical Functioning Score [ Time Frame: Change from baseline to three-month follow-up ]
    This well validated quality of life measure will be used to assess changes in patient perceived quality of life.
  • The Short-Form-36 Physical Functioning Score [ Time Frame: Change from baseline to six-month follow-up ]
    This well validated quality of life measure will be used to assess changes in patient perceived quality of life.
  • Walking Impairment Questionnaire [ Time Frame: Change from baseline to six-month follow-up ]
    The well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance.
  • Six-minute walk performance [ Time Frame: Change from baseline to six-month follow-up ]
    Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
  • Six-minute walk performance [ Time Frame: Change from baseline to 12-month follow-up ]
    See above regarding 6-minute walk protocol.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatocyte Growth Factor to Improve Functioning in PAD
Official Title  ICMJE Hepatocyte Growth Factor to Improve Functioning in Peripheral Artery Disease: The HI-PAD Study
Brief Summary HI-PAD is a placebo controlled double-blind randomized pilot clinical trial to determine whether VM202 may improve walking ability in people with lower extremity peripheral artery disease (PAD).
Detailed Description The HI-PAD study will randomize 39 people age 55 and older with PAD who do not have critical limb ischemia. The primary outcome is change in the six-minute walk distance at 3-month follow-up after the first study drug injection. A secondary outcome in change in six-minute walk distance at 6-month follow-up. Additional secondary outcomes are pain-free and maximal treadmill walking distance, calf biopsy measures of skeletal muscle regeneration, capillary density, and autophagy, and MRI-measured calf muscle perfusion at three-month follow-up. Investigators will also measure change in six-minute walk distance at 12-month follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Artery Disease
Intervention  ICMJE
  • Drug: VM202

    Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with an ankle brachial index <= 0.90. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.

    Note: Participants who have an ABI < 0.90 in only one leg will only receive injections in the leg with ABI < 0.90.

  • Other: Placebo

    Participants randomized to placebo will receive bilateral calf muscle injections of placebo (the excipient buffer formulation minus the VM202). Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.

    Note: Participants who have an ABI < 0.90 in only one leg will only receive injections in the leg with ABI < 0.90.

Study Arms  ICMJE
  • Active Comparator: VM202
    Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
    Intervention: Drug: VM202
  • Placebo Comparator: Placebo
    Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
    Intervention: Other: Placebo
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: November 30, 2017)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 55 or above
  • Symptomatic PAD, defined as exertion-induced ischemic calf muscle symptoms during the six-minute walk, during the baseline exercise stress test, or during daily walking activities. PAD will be defined as an ankle brachial index (ABI) < or = 0.90 at the baseline study visit or vascular lab evidence of PAD or angiographic evidence of significant PAD.

Exclusion Criteria:

  • Above- or below-knee amputation.
  • Critical limb ischemia, including individuals with gangrene and lower extremity ulcers.
  • Wheelchair-bound or requiring a cane or walker to ambulate.
  • Walking is limited by a symptom other than PAD.
  • Lower extremity revascularization, orthopedic surgery, cardiovascular event, coronary revascularization, or other major surgery in the previous three months and planned revascularization or major surgery during the next six months.
  • Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, or a life-threatening illness with life expectancy less than six months. [NOTE: Participants who only use oxygen at night may still qualify]
  • History of cancer within the last 5 years or incomplete cancer screening as recommended by the American Cancer Society. Specifically, participants will be asked to provide documentation regarding screening history for colon cancer and breast and cervical cancer (women), according to the American Cancer Society guidelines. Screening for colon cancer may consist of stool testing for blood in the past year. Men must either provide documentation regarding prostate cancer screening history or indicate after a telephone or in-person discussion with Dr. McDermott that they have elected to decline prostate cancer screening. A chest computed tomography will be performed for participants 55 to 74 years old with >30 pack year history of smoking, unless they have not smoked within the past 15 years, to screen for lung cancer that may exclude them. The study team may also perform colon, breast, and/or cervical cancer screenings as part of study participation. The study team will provide stool testing for blood for colon cancer screening, mammogram for breast cancer screening, and a Pap test for cervical cancer screening according to the participant's eligibility for these screening tests, using the American Cancer Society guidelines. Men who elect to have prostate cancer screening who have not had this completed with their physician can have a prostate specific antigen (PSA) test performed by study investigators. Participants who have a history of non-melanoma skin cancer (i.e.had basal cell carcinoma or squamous cell carcinoma of the skin) may still be eligible if the lesion was completely removed and there has been no evidence of recurrence in the past year.
  • Evidence of proliferative retinopathy.
  • Positive test for Human Immunodeficiency Virus, hepatitis B virus, hepatitis C virus or Human T-lymphotropic virus.
  • Mini-Mental Status Examination (MMSE) score <23 or dementia.
  • Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.]
  • Increase in angina or angina at rest.
  • Premenopausal women.
  • Non-English speaking.
  • Visual impairment that limits walking ability.
  • In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
  • Potential participants who have had symptoms from peripheral artery disease for less than six months will be excluded.
  • Potential participants who, after being advised of therapeutic options available for people with PAD, prefer to return to their physician to discuss alternative treatment (e.g. supervised exercise or revascularization). Potential participants may participate in the study after 12 weeks has passed since their last supervised exercise session or revascularization if they meet inclusion criteria.
  • Potential participants with a baseline six-minute walk value < 595 or > 1,520 feet will be excluded.
  • Potential participants with the following laboratory values will be excluded: a hemoglobin value < 8.0 g/dL, a white blood cell count < 3,000 cells per microliter, platelet count < 75,000/mm3, GFR < 20 mL/minute/1.73 M2, AST or ALT value > 3 times the upper limit of normal, or any other clinically significant laboratory abnormality which, in the opinion of the investigator, should exclude the participant.
  • Potential participants started on cilostazol within the past three months will be excluded. They may be evaluated for eligibility once three months has passed since beginning cilostazol.
  • Vulnerable populations (fetuses, pregnant women, children, prisoners, and institutionalized persons) and adults unable to consent will not be included in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary McDermott, MD 312-503-6419 mdm608@northwestern.edu
Contact: Kathryn Domanchuk, BS 312-503-6438 k-domanchuk@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363165
Other Study ID Numbers  ICMJE STU00205511
R21AG056903 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mary McDermott, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Helixmith Co., Ltd.
Investigators  ICMJE
Principal Investigator: Mary McDermott, MD Northwestern University
PRS Account Northwestern University
Verification Date November 2018

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