Phase 2
N=39
Hepatocyte Growth Factor to Improve Functioning in PAD
Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03363165 ↗Enrolled (actual)
39
Serious AEs
30.8%
Results posted
May 2024
Primary outcome: Primary: Six-minute Walk Distance — 17.01; 3.46 meters — p=0.7586
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VM202 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Six-minute Walk Distance |
5.02; 2.24 | 0.5647 |
| SECONDARY Maximal Treadmill Walking Time |
-0.59; 1.66 | 0.0298 sig |
| SECONDARY Calf Muscle Perfusion |
1.98; 2.68 | 0.4019 |
| SECONDARY Calf Muscle Biopsy Biochemical Measures (Satellite Cells - Total SCs/100 Fibers) |
-4.83; 3.45 | 0.2080 |
| SECONDARY Walking Impairment Questionnaire - Distance Score |
11.44; 9.31 | 0.5912 |
| SECONDARY The Short-Form-36 Physical Functioning Score |
11.98; 6.84 | 0.8414 |
| SECONDARY The Short-Form-36 Physical Functioning Score |
11.98; 6.84 | 0.8414 |
| SECONDARY Walking Impairment Questionnaire - Distance Score |
11.44; 9.31 | 0.5912 |
| SECONDARY Six-minute Walk Distance |
5.02; 2.24 | 0.5647 |
| SECONDARY Pain-free Treadmill Walking Time |
0.95; 0.45 | 0.6603 |
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).
Eligibility Criteria
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) 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. Participants who were treated for retinopathy at least 5 years prior to their baseline assessment who do not have evidence of proliferative retinopathy at the time of baseline assessment may still be eligible.
- Positive test for active Human Immunodeficiency Virus (HIV), hepatitis B virus, hepatitis C virus or Human T-lymphotropic virus. Patients who have positive antibodies for HIV, hepatitis B, or hepatitis C who do not have detectable viral load will be eligible for participation.
- Mini-Mental Status Examination (MMSE) score 1, 520 feet will be excluded.
- Potential participants with the following laboratory values will be excluded: a hemoglobin 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. Participants may undergo a serum electrophoresis and an immunofixation blood test if indicated to further evaluate abnormalities on the complete blood count if needed to assess study eligibility.
- 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.
Data sourced from ClinicalTrials.gov (NCT03363165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.