Clinical Trials List
Protocol NumberCSTC1-01
NCT Number(ClinicalTrials.gov Identfier)NCT01813305
2013-11-15 - 2019-12-31
Phase II
Terminated3
A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of CSTC1 in Patient with Diabetic Foot Ulcers
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Trial Applicant
麗晶診所
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Sponsor
Charsire Biotechnology Corp.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- HSIAO-CHEN LEE Division of Plastic Surgery
- 張智豪 Division of Plastic Surgery
- Yen Ting Sheen Division of Plastic Surgery
- Shu-Hung Huang Division of Plastic Surgery
- Yun-Nan Lin Division of Plastic Surgery
- Yur-Ren Kuo Division of Plastic Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chien-Liang Ho Division of Plastic Surgery
- 林寶彥 Division of Plastic Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Diabetic Foot Ulcers
Objectives
To evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers
Test Drug
CSTC1
Active Ingredient
CSTC1
Dosage Form
ointment
Dosage
30
Endpoints
The incidence of complete ulcer closure during up to 12 weeks
of treatment period
Complete ulcer closure is defined as 100% skin reepithelialization without drainage or dressing requirements
confirmed at two consecutive study visits 2 weeks apart.
Subjects with complete ulcer closure at week-12 visit and
confirmed at week-14 visit will be considered as success.
of treatment period
Complete ulcer closure is defined as 100% skin reepithelialization without drainage or dressing requirements
confirmed at two consecutive study visits 2 weeks apart.
Subjects with complete ulcer closure at week-12 visit and
confirmed at week-14 visit will be considered as success.
Inclution Criteria
1. With either gender aged at least 20 years old
2. With at least one diabetic foot ulcer (including ulcers on the lower legs) and not healing for at least 4 weeks. The
largest diabetic foot ulcer will be selected as target ulcer. If two or more ulcers have the largest size, the one with
worst grade will be selected. If two or more ulcers have the largest size and grade, the one with longest duration will
be selected.
3. The target ulcer is classified as grade 1 to 2 ulcer according to modified Wagner system and with ulcer size
of 1cm2 to 50 cm2
4. The target ulcer should be confirmed without active infection
5. Subject should be free of any necrosis or infection in soft and bone tissue;
6. Subject has signed the written informed consent form
2. With at least one diabetic foot ulcer (including ulcers on the lower legs) and not healing for at least 4 weeks. The
largest diabetic foot ulcer will be selected as target ulcer. If two or more ulcers have the largest size, the one with
worst grade will be selected. If two or more ulcers have the largest size and grade, the one with longest duration will
be selected.
3. The target ulcer is classified as grade 1 to 2 ulcer according to modified Wagner system and with ulcer size
of 1cm2 to 50 cm2
4. The target ulcer should be confirmed without active infection
5. Subject should be free of any necrosis or infection in soft and bone tissue;
6. Subject has signed the written informed consent form
Exclusion Criteria
1. With active osteomyelitis
2. With target ulcer size decreased by at least 30% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before Randomization visit
3. With poor nutritional status (albumin < 2g/dl), poor diabetic control (HbA1c > 12%), anemia (hemoglobin < 8 g/dL), a leukocyte counts < 2,000/mm3 , abnormal liver function (AST, ALT>3 x upper limit of normal range)
4. Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents within 28 days prior to Screening visit
5. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
6. Receiving revascularization surgery or endovascular therapy performed < 8 weeks before entry in the study
7. With known or suspected hypersensitivity to any ingredients of study product and vehicle
8. With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study
9. Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period
10. Enrollment in any investigational drug trial within 4 weeks before entering this study
11. With any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the subject
2. With target ulcer size decreased by at least 30% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before Randomization visit
3. With poor nutritional status (albumin < 2g/dl), poor diabetic control (HbA1c > 12%), anemia (hemoglobin < 8 g/dL), a leukocyte counts < 2,000/mm3 , abnormal liver function (AST, ALT>3 x upper limit of normal range)
4. Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents within 28 days prior to Screening visit
5. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
6. Receiving revascularization surgery or endovascular therapy performed < 8 weeks before entry in the study
7. With known or suspected hypersensitivity to any ingredients of study product and vehicle
8. With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study
9. Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period
10. Enrollment in any investigational drug trial within 4 weeks before entering this study
11. With any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the subject
The Estimated Number of Participants
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Taiwan
125 participants
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Global
125 participants
