Diabetic Foot Ulcers Clinical Trial
Official title:
Open Label Pharmacokinetic Study of Granexin® Gel in Patients With Diabetic Foot Ulcers
The purpose of this study is to determine the systemic exposure of Granexin® gel after topical application to human subjects' diabetic foot ulcers.
The objective of this study is to ascertain the systemic exposure of the active ingredient in
Granexin® gel (aCT1 peptide) after topical application to diabetic foot ulcers using
pharmacokinetic analysis. It is planned that a total of 16 patients with diabetic foot ulcers
will receive Granexin® gel treatment plus standard of care in this one arm study. The study
includes a screening period (1 week) and a treatment period (1 week) which occur sequentially
for a given patient. The baseline day, which demarcates the beginning of the treatment
period, is the designated as Day 0. Screening procedures are initially conducted on Day -7.
A target foot ulcer is identified at screening and patient eligibility is confirmed at
screening and then again at the beginning of the Day 0 (baseline) visit. A patient enrolled
in the study may have multiple ulcers on the same or either foot; in this case, all ulcers
will be treated with Granexin® gel, but only ulcer(s) meeting the following criteria will be
designated as the target ulcer(s) and will determine eligibility: >4cm2 in post debridement
of at least 4 weeks duration.
The treatment period for a given patient begins on Day 0 and ends one week later; the last
scheduled day of the treatment period is designated as Day 7. During the treatment period,
each patient is scheduled to receive topical treatment with study drug gel (3 applications
total) administered by study staff at scheduled study site visits at each of the following
time points: Day 0, Day 3, and Day 7. All patients, regardless of treatment assignment, also
receive standard-of-care treatment at scheduled study visits during the treatment period.
Study drug pre-application blood samples will be collected from each patient at Day 0, Day 3,
and Day 7. Study drug post-application blood samples will be collected at Day 0 and Day 7 at
time points specified in the protocol. These blood samples will be shipped to a designated
laboratory for pharmacokinetic analysis.
Safety will be assessed during the treatment period by monitoring adverse events, measuring
vital signs at each visit, performing physical examinations, electrocardiograms (ECG), as
well as pharmacokinetic (PK) blood analysis.
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