Overview

CSTC1 for Diabetic Foot Ulcers Phase II Study

Status:
Completed
Trial end date:
2020-01-07
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Charsire Biotechnology Corp.
Collaborator:
ASKLEP Inc.
Criteria
Inclusion Criteria:

- With either gender aged at least 20 years old;

- With a diabetic ulcer (which is defined as the target ulcer) on the foot and not
healing for at least 2 weeks;

- The target ulcer is classified as grade 1 or 2 ulcer according to modified Wagner
system;

- The target ulcer should show "infection control" at investigator's discretion;

- Subject should be free of any necrosis or infection in soft and bone tissue;

- Subject has signed the written informed consent form

Exclusion Criteria:

- With active osteomyelitis;

- With target ulcer size decreased by at least 50% after at least 2 weeks of
standard-of-care-only period or any other recorded regular therapy before
Randomization visit;

- With poor nutritional status (albumin < 3g/dl), poor diabetic control (HbA1c > 12%),
anemia (hemoglobin<10 g/dL), a leukocyte counts < 1,000/mm3, abnormal liver function
(AST, ALT>3 x upper limit of normal range);

- Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic
agents;

- Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;

- Receiving revascularization surgery performed <8 weeks before entry in the study;

- With known or suspected hypersensitivity to any ingredients of study product and
vehicle;

- With coronary heart disease with myocardial infarction, coronary artery bypass graft
(CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior
to study;

- Pregnant or lactating or premenopausal with childbearing potential but not taking
reliable contraceptive method(s) during the study period;

- Enrollment in any investigational drug trial within 4 weeks before entering this
study;

- With any uncontrolled illness judged by the investigator that entering the trial may
be detrimental to the subject.