SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease

NCT02544204 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-11-02

No results posted yet for this study

Summary

To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.

Conditions

  • Peripheral Arterial Disease

Interventions

BIOLOGICAL

JVS-100

Biological/Vaccine: JVS-100 Intramuscular Injection

BIOLOGICAL

Placebo

Biological/Vaccine: Placebo Intramuscular Injection

Sponsors & Collaborators

  • Juventas Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-09-30
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544204 on ClinicalTrials.gov