Evidence map›Paper›PMID 39778757›Full record

Trial reportJournal of vascular surgery2025

Hepatocyte growth factor for walking performance in peripheral artery disease.

Mary M McDermott, Robert Sufit, Kathryn J Domanchuk, Nicholas J Volpe, Kate Kosmac, Charlotte A Peterson, Lihui Zhao, Lu Tian, Dongxue Zhang, Shujun Xu and 11 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of vascular surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Mary M McDermottDepartment of Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL; Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: mdm608@northwestern.edu.
Robert SufitNorthwestern University Feinberg School of Medicine, Department of Neurology, Chicago, IL.
Kathryn J DomanchukDepartment of Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Nicholas J VolpeDepartment of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, IL.
Kate KosmacDepartment of Physical Therapy, Augusta University, Augusta, GA.
Charlotte A PetersonCenter for Muscle Biology, University of Kentucky, Lexington, KY.
Lihui ZhaoDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Lu TianDepartment of Health Research and Policy, Stanford University, Palo Alto, CA.
Dongxue ZhangDepartment of Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Shujun XuDepartment of Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Ahmed IsmaeelCenter for Muscle Biology, University of Kentucky, Lexington, KY.
Luigi FerrucciNational Institute on Aging, Division of Intramural Research, Baltimore, Maryland.
Nishant D ParekhDepartment of Radiology, Northwestern University Feinberg School of Medicine, Chicago, IL.
Donald Lloyd-JonesDepartment of Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL; Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Christopher M KramerDepartments of Medicine and Radiology, University of Virginia Health, Charlottesville, VA.
Christiaan LeeuwenburghDepartment of Aging and Geriatric Research, University of Florida, Gainesville, FL.
Karen HoDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL.
Michael H CriquiDivision of Preventive Medicine, University of California San Diego, La Jolla, CA.
Tamar PolonskyDepartment of Medicine, University of Chicago, Chicago, IL.
Jack M GuralnikDepartment of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD.
Melina R KibbeDepartment of Surgery, University of Virginia Health, Charlottesville, VA.

Funding

Hepatocyte growth factor to Improve Functioning in PAD: the HI-PAD StudyR21AG056903 · NIA · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MCDERMOTT, MARY MCGRAE · 2017 to 2018
$388k
NIA NIH HHS R21 AG056903
6 · The paper itself

Abstract

backgroundVM202 is a plasmid encoding two isoforms of hepatocyte growth factor. In preclinical studies, hepatocyte growth factor stimulated angiogenesis and muscle regeneration. This preliminary clinical trial tested the hypothesis that VM202 injections in gastrocnemius muscle would improve walking performance in people with mild to moderate and symptomatic lower extremity peripheral artery disease (PAD).

methodsIn a double-blind clinical trial, patients with PAD were randomized to gastrocnemius muscle injections of either 4 mg of VM202 or placebo every 14 days for four treatments. The primary outcome was 6-month change in 6-minute walk distance. Secondary outcomes included 3-month change in treadmill walking time and gastrocnemius muscle biopsy measures. In this preliminary trial, statistical significance was prespecified as a one-sided P value of less than .10.

resultsThirty-nine participants with PAD (64.1% Black, 28.2% female) were randomized. Adjusting for age, race, smoking, and baseline performance, VM202 did not improve 6-minute walk at 6-month follow-up, compared with placebo (-13.5 m; 90% confidence interval [CI], -38.5 to +∞). At the 3-month follow-up, VM202 improved the maximum treadmill walking time (+2.38 minutes; 90% CI, +1.08 to +∞; P = .014) and increased central nuclei abundance in gastrocnemius muscle (+5.86; 90% CI, +0.37 to +∞; P = .088), compared with placebo. VM202 did not significantly improve pain-free walking distance (difference, +0.30 minutes; 90% CI, -1.10 to +∞; P = .39), calf muscle perfusion (difference, +1.80 mL/min per 100 g tissue; 90% CI, -3.80 to +∞; P = .33), or the Walking Impairment Questionnaire distance score (difference, +2.02; 90% CI, -8.11 to +∞; P = .40). In post hoc analyses, VM202 significantly improved 6-minute walk in PAD participants with diabetes mellitus at 6-month follow-up (+34.19; 90% CI, 4.04 to +∞; P = .075), but had no effect in people without diabetes (interaction P = .079).

conclusionsThese data do not support gastrocnemius injections of VM202 to improve 6-minute walk in PAD. Secondary outcomes suggested potential benefit of VM202 on skeletal muscle measures and treadmill walking, whereas post hoc analyses suggested benefit in PAD participants with diabetes.

Indexed as

Exercise ToleranceGenetic TherapyHepatocyte Growth FactorIntermittent ClaudicationMuscle, SkeletalPeripheral Arterial DiseaseWalkingAgedDouble-Blind MethodFemaleHumansInjections, IntramuscularMaleMiddle AgedRecovery of FunctionTime FactorsHepatocyte Growth FactorHGF protein, human6-Minute walkClinical trialGene therapyIntermittent claudicationmobilityPeripheral artery disease

Identifiers

PMID39778757
PMCPMC12104005

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.