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Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers

NCT04267640 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-12-22

No results posted yet for this study

Summary

This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor \[HGF\] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.

Conditions

  • Peripheral Artery Disease
  • Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
  • Chronic Limb Threatening Ischemia
  • Ischemic Ulcer of Foot

Interventions

BIOLOGICAL

AMG0001

AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly

BIOLOGICAL

Placebo

Matching placebo

Sponsors & Collaborators

  • AnGes USA, Inc.

    lead INDUSTRY

Principal Investigators

  • David G Armstrong, MD, DPM, PhD · Keck School of Medicine, USC

  • Michael S Conte, MD · Division of Vascular and Endovascular Surgery, UCSF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2022-07-31
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT04267640 on ClinicalTrials.gov