Clinical trial NCT04267640: Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
Official title: A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects Who Have Peripheral Ischemic Ulcers of the Lower Extremity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral Artery Disease
Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
Chronic Limb Threatening Ischemia
Ischemic Ulcer of Foot
Lead sponsor: AnGes USA, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Complete ulcer healing at 6 months
timeFrame: Month 6
measure: Time to complete ulcer healing
timeFrame: Month 12
Secondary outcomes:
measure: The percentage reduction of ulcer size from baseline
timeFrame: Months 4, 6, 8, 10, 12
measure: Hemodynamic measurements of toe pressure (TP)
timeFrame: Months 4, 6, 8, 10, 12
measure: Hemodynamic measurements of ankle systolic pressure (ASP)
timeFrame: Months 4, 6, 8, 10, 12
measure: Hemodynamic measurements of ankle brachial index (ABI)
timeFrame: Months 4, 6, 8, 10, 12
measure: Hemodynamic measurements of toe brachial index (TBI)
timeFrame: Months 4, 6, 8, 10, 12
measure: Hemodynamic measurements of TcPO2
timeFrame: Months 4, 6, 8, 10, 12
measure: Visual Analogue Scale (VAS)
timeFrame: Months 4, 6, 8, 10, 12
measure: Occurrence of New Ulcer of the Index leg
timeFrame: Months 4, 6, 8, 10, 12
measure: Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg
timeFrame: Months 4, 6, 8, 10, 12
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: ILD Research Center
state: California
city: Downey
country: United States
facility: Rancho Research Institute
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform, Inc.
state: California
city: Los Angeles
country: United States
facility: Felix Sigal, D.P.M. A Professional Corporation
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research Inc.
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Santa Barbara
country: United States
facility: Goleta Valley Cottage Hospital
state: California
city: Deerfield Beach
country: United States
facility: BRCR Global
state: Florida
city: South Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Tamarac
country: United States
facility: Barry University Clinical Research
state: Florida
city: Winter Park
country: United States
facility: Guardian Research/Florida Cardiology
state: Florida
city: Belleville
country: United States
facility: Gateway Clinical Trials, LLC
state: Illinois
city: North Chicago
country: United States
facility: Rosalind Franklin University Health Clinics
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital / Harvard Medical School
state: Massachusetts
city: Las Vegas
country: United States
facility: Advanced Foot & Ankle Center
state: Nevada
city: Cary
country: United States
facility: Vascular Solutions of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at the Christ Hospital
state: Ohio
city: Youngstown
country: United States
facility: Lower Extremity Institute for Research and Therapy (LEIRT)
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
city: Salem
country: United States
facility: Foot and Ankle Associates of Southwest Virginia
state: Virginia
Study officials:
affiliation: Keck School of Medicine, USC
name: David G Armstrong, MD, DPM, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Vascular and Endovascular Surgery, UCSF
name: Michael S Conte, MD
role: PRINCIPAL_INVESTIGATOR
References: