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.