Status:
COMPLETED
CSTC1 for Diabetic Foot Ulcers Phase II Study
Lead Sponsor:
Charsire Biotechnology Corp.
Collaborating Sponsors:
ASKLEP Inc.
Conditions:
Diabetic Foot Ulcer
Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
Detailed Description
This study was designed as a randomized, double-blind, vehicle-controlled, multiple-center, and parallel trial to evaluate the efficacy and safety of CSTC1 in patients with diabetic foot ulcers (DFU)....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 9 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2020
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01813305
Start Date
July 9 2014
End Date
January 7 2020
Last Update
April 12 2022
Active Locations (1)
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1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan