FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease

August 17, 2026 updated by: Venturis Therapeutics, Inc.

A Phase 1, Open Label, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Peripheral Arterial Disease Patients With Intermittent Claudication

FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

FGF-1 administered by intramuscular injection for the treatment of peripheral arterial disease with intermittent claudication. Eligible patients are allocated to one of three treatment arms. Patients within each dosing group will be randomized between study drug and vehicle control. Safety, pharmacokinetics, and cardiovascular improvement will be evaluated at day 1 and weeks 1, 4 and 12 post dosing.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Venturis Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.
  2. Age must be ≥50 and ≤75 years of age with a life expectancy of > 1 year and leg survival > 6 months. Patients >75 and ≤80 years of age will be considered if they show no signs of cognitive or muscle function decline and are fully able to comply with the protocol.
  3. Patients must have experienced intermittent claudication for at least 6 months and have been stable for the past 3 months.
  4. Patients must have peripheral arterial disease, as confirmed by a resting ABI ≥0.40 and <0.90 based on at least one leg as measured using both the dorsal pedis and posterior tibial arteries.
  5. Stenosis of >70% up to total occlusion must be present in the popliteal artery and/or in the tibial peroneal trunk or at least 2 tibial arteries above the ankle without inflow limitation of the popliteal artery. Adequate popliteal inflow is defined as continuous flow from the abdominal aorta, iliac, common femoral and superficial femoral with any stenosis < 50% as determined either by intra-arterial DSA, CTA or Gd CE-MRA.
  6. The screening Gardner treadmill test peak walking times (PWT) must be >1 minute and < 12 minutes and limited by pain in one or both calves.
  7. Preexisting medication regime must be stable for 6 weeks preceding dosing.

Exclusion Criteria

  1. Evidence of critical leg ischemia, i.e. ischemic rest pain or ischemic ulceration
  2. Treadmill walking limited by conditions other than intermittent claudication including arthritis, angina and dyspnea
  3. Lower limb amputation of, or in, either leg including toes
  4. Evidence of limb ischemia from immunologic or inflammatory disorders
  5. Leg surgery or revascularization within past 6 months or peripheral angioplasty within past 3 months or anticipated during study
  6. Participation in any investigational device or drug trial within the past 6 months
  7. Myocardial infarction, unstable angina, stroke or ischemic attack within past 6 months
  8. New York Heart Association (NYHA) class II, III or IV heart failure, restrictive or hypertrophic cardiomyopathy or severe valvular disease
  9. QTc elongation greater than 450 ms in males or 460 ms in females
  10. PT (INR), PTT, urinalysis, thyroid function (T3, T4, TSH) outside normal limits
  11. Hemorrhage or thrombotic events (e.g. deep vein thrombosis) within past 6 months
  12. Thrombocytopenia (<100,000/µl), history of heparin-induced thrombocytopenia
  13. Major surgery with the past 6 months
  14. Positive proliferative retinopathy exam
  15. Present of any type of cancer or history of cancer except past (but not present) basal cell dermal carcinoma not on either leg
  16. Inflammatory or progressive fibrotic or myelofibrotic disorders
  17. Patients experiencing bacterial or viral infection (e.g. hepatitis or HIV) or who may otherwise be febrile
  18. Hemoglobin A1c(HgbA1c) of >8%
  19. Type I diabetes
  20. Total fasting cholesterol >200
  21. Uncontrolled hypertension (≥160 systolic or ≥100 diastolic pressure) or hypotension (<90 systolic or <60 diastolic pressure)
  22. Disease or drug (e.g. systemic corticosteroid) immuno-compromised
  23. Hepatic dysfunction as defined either by AST or ALT > 2.0 times the upper limit of normal
  24. Serum creatinine of ≥ 2.5 mg/dl
  25. Proteinuria (urine protein/creatinine ratio > 3)
  26. Antiproliferative drugs (e.g. thalidomide, hydroxyurea)
  27. Radiation therapy
  28. Implanted devices not compatible with strong magnetic fields
  29. Life expectance of less than 1 year
  30. Females who are premenopausal and not sterilized or using adequate birth control or are either pregnant, intend to become pregnant or are nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
The dosing groups correspond to total doses of 0 µg/kg of FGF-1.
Drug: Placebo
Vehicle: 0 µg/kg
Active Comparator: Human FGF-1
The dosing groups correspond to total doses of either 3, 10 or 30 µg/kg of FGF-1.
Drug: FGF-1

Doses of FGF-1: 3 ug/kg; 10 ug/kg; 30 ug/kg

Low dose: 3.0 μg/kg Mid dose: 10 μg/kg High dose: 30 µg/kg

Other Names:
  • Acidic FGF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as a measure of safety and tolerability of i.m. injected Cardio Vascu Grow TM, a recombinant Human Fibroblast Growth Factor-1 (FGF-1-141)
Time Frame: From enrollment through study completion, an average of 12 weeks
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)
From enrollment through study completion, an average of 12 weeks
Change from baseline in safety laboratory measurements at 12 weeks
Time Frame: From enrollment through study completion, an average of 12 weeks
Safety laboratory evaluations on hematology, serum chemistry, and urinalysis
From enrollment through study completion, an average of 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma FGF-1 (1-141) pharmacokinetic measurements at pre-dose, 5, 15, and 30 minutes and at 1, 2, 4, 6, 10, and 24 hours
Time Frame: From enrollment through study completion, an average of 12 weeks
Pharmacokinetic plasma concentrations of FGF-1 (1-141)
From enrollment through study completion, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Venturis Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2028

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2007

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVBT-2006-PAD-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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