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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot

In brief

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.

Key facts

Study ID

NCT04267640

Run by

AnGes USA, Inc.

People needed

60

Starts

2020-01-30

Expected to finish

2023-01-01

Last updated by the study team

2021-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ILD Research Center — Carlsbad, California, United States (enrolling)
• Rancho Research Institute — Downey, California, United States (enrolling)
• Limb Preservation Platform, Inc. — Fresno, California, United States (enrolling)
• Felix Sigal, D.P.M. A Professional Corporation — Los Angeles, California, United States (enrolling)
• Center for Clinical Research Inc. — San Francisco, California, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Goleta Valley Cottage Hospital — Santa Barbara, California, United States (enrolling)
• BRCR Global — Deerfield Beach, Florida, United States (enrolling)
• Doctors Research Network — South Miami, Florida, United States (enrolling)
• Barry University Clinical Research — Tamarac, Florida, United States (enrolling)
• Guardian Research/Florida Cardiology — Winter Park, Florida, United States (enrolling)
• Gateway Clinical Trials, LLC — Belleville, Illinois, United States (enrolling)
• Rosalind Franklin University Health Clinics — North Chicago, Illinois, United States (enrolling)
• Brigham and Women's Hospital / Harvard Medical School — Boston, Massachusetts, United States (enrolling)
• Advanced Foot & Ankle Center — Las Vegas, Nevada, United States (enrolling)
• Vascular Solutions of North Carolina — Cary, North Carolina, United States (enrolling)
• The Lindner Center for Research and Education at the Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Lower Extremity Institute for Research and Therapy (LEIRT) — Youngstown, Ohio, United States (enrolling)
• Oregon Health & Sciences University — Portland, Oregon, United States (enrolling)
• Foot and Ankle Associates of Southwest Virginia — Salem, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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