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Growth Factor

AMG0001 for Peripheral Arterial Disease

Phase 2
Waitlist Available
Led By David G Armstrong, MD, DPM, PhD
Research Sponsored by AnGes USA, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 4, 6, 8, 10, 12

Summary

This trial will test a gene therapy to see if it can improve healing and blood flow in people with peripheral artery disease.

Eligible Conditions
  • Leg Ulcer
  • Peripheral Arterial Disease
  • Ischemic Foot Ulcer
  • Chronic Limb Threatening Ischemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 4, 6, 8, 10, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 4, 6, 8, 10, 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete ulcer healing at 6 months
Time to complete ulcer healing
Secondary study objectives
Hemodynamic measurements of TcPO2
Hemodynamic measurements of ankle brachial index (ABI)
Hemodynamic measurements of ankle systolic pressure (ASP)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: AMG0001 8mgExperimental Treatment1 Intervention
AMG0001 8mg + standard wound care
Group II: AMG0001 4mgExperimental Treatment1 Intervention
AMG0001 4mg + standard wound care
Group III: PlaceboPlacebo Group1 Intervention
Placebo + standard wound care

Find a Location

Who is running the clinical trial?

AnGes USA, Inc.Lead Sponsor
5 Previous Clinical Trials
196 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
141 Patients Enrolled for Peripheral Arterial Disease
David G Armstrong, MD, DPM, PhDPrincipal InvestigatorKeck School of Medicine, USC
Michael S Conte, MDPrincipal InvestigatorDivision of Vascular and Endovascular Surgery, UCSF
1 Previous Clinical Trials
67 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
67 Patients Enrolled for Peripheral Arterial Disease
~10 spots leftby Nov 2025
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