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Growth Factor

AMG0001 for Ischaemic Leg Ulcer

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

Awards & highlights

Study 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

Ischaemic Leg Ulcer
Peripheral Arterial Disease
Ischemic Foot Ulcer
Chronic Limb Threatening Ischemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 4, 6, 8, 10, 12

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete ulcer healing at 6 months

Time to complete ulcer healing

Secondary outcome measures

Hemodynamic measurements of TcPO2

Hemodynamic measurements of ankle brachial index (ABI)

Hemodynamic measurements of ankle systolic pressure (ASP)

+6 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AnGes USA, Inc.Lead Sponsor

5 Previous Clinical Trials

196 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent are medical centers participating in this clinical experiment?

"This trial is accessible at 22 different sites spanning from Pasadena to Deerfield Beach and Carlsbad. To minimize travel requirements, it's advised that applicants select the nearest location for their enrolment."

Answered by AI

How many people have participated in this medical experiment thus far?

"To make this trial a success, AnGes USA, Inc. must find 60 eligible patients for the research study being conducted at Chesapeake Research Group in Pasadena and BRCR Global in Deerfield Beach."

Answered by AI

Has the Federal Drug Administration given its stamp of approval to AMG0001?

"The safety of AMG0001 is assessed to be a 2 on the 1-3 scale. This evaluation takes into account that this trial is presently in its second phase, thus having evidence confirming safety but no proof yet demonstrating effectiveness."

Answered by AI

Are there still opportunities for participation in this clinical experiment?

"Indeed, the clinicaltrials.gov database affirms that this research study is currently recruiting participants. It was first published on January 30th 2020 and has information updated as recently as December 21st 2021. This trial requires 60 volunteers from 22 distinct sites for completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04267640.

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