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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
ILD Research Center
Carlsbad, California, United States
Complete ulcer healing at 6 months
Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
Time frame: Month 6
Time to complete ulcer healing
Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
Time frame: Month 12
The percentage reduction of ulcer size from baseline
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe pressure (TP)
Measure of baseline and change from baseline for hemodynamic parameters
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle systolic pressure (ASP)
Measure of baseline and change from baseline for hemodynamic parameters
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle brachial index (ABI)
Measure of baseline and change from baseline for hemodynamic parameters
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe brachial index (TBI)
Measure of baseline and change from baseline for hemodynamic parameters
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of TcPO2
Measure of baseline and change from baseline for hemodynamic parameters
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Rancho Research Institute
Downey, California, United States
RECRUITINGLimb Preservation Platform, Inc.
Fresno, California, United States
RECRUITINGFelix Sigal, D.P.M. A Professional Corporation
Los Angeles, California, United States
RECRUITINGCenter for Clinical Research Inc.
San Francisco, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGGoleta Valley Cottage Hospital
Santa Barbara, California, United States
RECRUITINGBRCR Global
Deerfield Beach, Florida, United States
RECRUITINGDoctors Research Network
South Miami, Florida, United States
RECRUITINGBarry University Clinical Research
Tamarac, Florida, United States
RECRUITING...and 10 more locations
Time frame: Months 4, 6, 8, 10, 12
Visual Analogue Scale (VAS)
Measure of baseline and change from baseline for VAS. VAS is a 10-cm line (with score ranges 0 to 10), oriented horizontally; the left end of the line (0 mark) indicates "no pain"; the right end indicates "pain as bad as it can be."
Time frame: Months 4, 6, 8, 10, 12
Occurrence of New Ulcer of the Index leg
Number of subjects and proportions with new ulcer
Time frame: Months 4, 6, 8, 10, 12
Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg
Number of subjects and proportions with major/minor amputation or revascularization
Time frame: Months 4, 6, 8, 10, 12