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

2020-02-17 18:20:57 | BioPortfolio

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.

Description

This is a Phase 2, double-blind, randomized, placebo-controlled, parallel group study. Approximately 60 male or female subjects aged 18 years or older with one shallow foot ulcer and mild/moderate ischemia due to peripheral artery disease (PAD) will be randomized in a 1:1:1 ratio to one of 3 treatment groups:

- 4.0 mg AMG0001 intramuscular (IM) (n = 20)

- 8.0 mg AMG0001 IM (n = 20)

- Placebo IM (n = 20)

Study Design

Conditions

Peripheral Artery Disease

Intervention

AMG0001, Placebo

Location

Foot and Ankle Associates of Southwest Virginia
Salem
Virginia
United States
24153

Status

Recruiting

Source

AnGes USA, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-02-17T18:20:57-0500

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