Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
- Conditions
- Peripheral Artery DiseaseIschaemic Ulcer of Lower Leg Due to Atherosclerotic DiseaseChronic Limb Threatening IschemiaIschemic Ulcer of Foot
- Interventions
- Biological: PlaceboBiological: AMG0001
- Registration Number
- NCT04267640
- Lead Sponsor
- AnGes USA, Inc.
- Brief 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.
- Detailed 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Documented diagnosis of PAD and mild/moderate foot ischemia (WIFI ischemia grades 1, 2)
- A single measurable ulcer of ≥ 1 cm2 and ≤ 10 cm2 on a lower extremity without evidence of infection or gangrene and no evidence of bone and/or tendon involvement at randomization
- Subjects will undergo protocol-defined standardized wound care during the screening period and through 12 months from the first dose of investigational product
- Subjects who have a diagnosis of diabetes must be considered stable with no changes in diabetic medication regimen anticipated during the study period. Subjects who have a diagnosis of diabetes must have a HbA1c of ≤12% at Screening
- Subjects who have excessive tissue necrosis that is unlikely to benefit from medication, or those subjects who, in the opinion of the Investigator, are felt likely to require revascularization within 1 month of screening
- Subjects with severe limb ischemia
- Subjects who are considered likely to require a major amputation (at or above the ankle) within 3 months of screening
- Subjects with deep ulcerations with bone or tendon exposure, or uncontrolled infection, or with the largest ulcer that is >10 cm2 in area
- Subjects with hemodynamically significant aorto-iliac occlusive disease
- Subjects who have had a technically successful revascularization by surgery or angioplasty within 2 months. If subjects are more than two months from revascularization and still meet the inclusion criteria, they may be considered for enrollment. Subjects who have had a technically unsuccessful attempt at revascularization may be enrolled at least one week from the procedure
- Subjects currently receiving immunosuppressive medication, systematically administered steroid therapy, chemotherapy or radiation therapy. Inhaled and topical steroid therapies are allowed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo + standard wound care AMG0001 4mg AMG0001 AMG0001 4mg + standard wound care AMG0001 8mg AMG0001 AMG0001 8mg + standard wound care
- Primary Outcome Measures
Name Time Method Complete ulcer healing at 6 months Month 6 Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
Time to complete ulcer healing Month 12 Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
- Secondary Outcome Measures
Name Time Method The percentage reduction of ulcer size from baseline Months 4, 6, 8, 10, 12 Hemodynamic measurements of toe pressure (TP) Months 4, 6, 8, 10, 12 Measure of baseline and change from baseline for hemodynamic parameters
Hemodynamic measurements of TcPO2 Months 4, 6, 8, 10, 12 Measure of baseline and change from baseline for hemodynamic parameters
Visual Analogue Scale (VAS) Months 4, 6, 8, 10, 12 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."
Hemodynamic measurements of ankle systolic pressure (ASP) Months 4, 6, 8, 10, 12 Measure of baseline and change from baseline for hemodynamic parameters
Occurrence of New Ulcer of the Index leg Months 4, 6, 8, 10, 12 Number of subjects and proportions with new ulcer
Hemodynamic measurements of ankle brachial index (ABI) Months 4, 6, 8, 10, 12 Measure of baseline and change from baseline for hemodynamic parameters
Hemodynamic measurements of toe brachial index (TBI) Months 4, 6, 8, 10, 12 Measure of baseline and change from baseline for hemodynamic parameters
Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg Months 4, 6, 8, 10, 12 Number of subjects and proportions with major/minor amputation or revascularization
Trial Locations
- Locations (20)
ILD Research Center
🇺🇸Carlsbad, California, United States
Oregon Health & Sciences University
🇺🇸Portland, Oregon, United States
Limb Preservation Platform, Inc.
🇺🇸Fresno, California, United States
BRCR Global
🇺🇸Deerfield Beach, Florida, United States
Felix Sigal, D.P.M. A Professional Corporation
🇺🇸Los Angeles, California, United States
Goleta Valley Cottage Hospital
🇺🇸Santa Barbara, California, United States
Guardian Research/Florida Cardiology
🇺🇸Winter Park, Florida, United States
Vascular Solutions of North Carolina
🇺🇸Cary, North Carolina, United States
Lower Extremity Institute for Research and Therapy (LEIRT)
🇺🇸Youngstown, Ohio, United States
The Lindner Center for Research and Education at the Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Advanced Foot & Ankle Center
🇺🇸Las Vegas, Nevada, United States
Rancho Research Institute
🇺🇸Downey, California, United States
Doctors Research Network
🇺🇸South Miami, Florida, United States
Foot and Ankle Associates of Southwest Virginia
🇺🇸Salem, Virginia, United States
Center for Clinical Research Inc.
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Barry University Clinical Research
🇺🇸Tamarac, Florida, United States
Gateway Clinical Trials, LLC
🇺🇸Belleville, Illinois, United States
Rosalind Franklin University Health Clinics
🇺🇸North Chicago, Illinois, United States
Brigham and Women's Hospital / Harvard Medical School
🇺🇸Boston, Massachusetts, United States