This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not respond adequately to standard wound care. Participants across multiple sites will be assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12 weeks in addition to standard wound care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
UTTR1147A matching placebo will be administered SC.
UTTR1147A will be administered SC.
East Valley Foot and Ankle Specialists
Mesa, Arizona, United States
Center for Clinical Research Inc.; i
San Francisco, California, United States
Animas Foot and Ankle
Durango, Colorado, United States
GF Professional Research Group Corporation
Miami Lakes, Florida, United States
Podiatry 1st
Belleville, Illinois, United States
Percentage of Participants with Adverse Events
Time frame: Baseline up to Day 141
Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12
Time frame: Baseline, Weeks 6 and 12
Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies
Time frame: Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)
Serum Concentration of UTTR1147A
Time frame: Pre-dose (0 h) on Days 1, 22, 43, and 64, on Days 4, 8, 71, 85, and 99, early termination (up to Day 141)
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Clinical Research Associates Of Central Pa , Llc
Altoona, Pennsylvania, United States
Futuro Clinical Trials
McAllen, Texas, United States
Endeavor Clinical Trials PA
San Antonio, Texas, United States
1Foot 2Foot Centre for Foot & Ankle Care PC
Suffolk, Virginia, United States
Steven M. Waldman, SC
Wauwatosa, Wisconsin, United States
...and 22 more locations