CSTC1 for Diabetic Foot Ulcers Phase II Study
This study is not yet open for participant recruitment.
Verified March 2013 by Charsire Biotechnology Corp.
Sponsor:
Charsire Biotechnology Corp.
Collaborator:
ASKLEP Inc.
Information provided by (Responsible Party):
Charsire Biotechnology Corp.
ClinicalTrials.gov Identifier:
NCT01813305
First received: March 12, 2013
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Foot Ulcer Diabetes Mellitus Wounds |
Drug: CSTC1 Drug: CSTC1 Matched vehicle |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized,Double-Blind,Vehicle-controlled,Parallel,Phase II Study to Evaluate Efficacy and Safety of CSTC1 in Patient With Diabetic Foot Ulcers |
Resource links provided by NLM:
Further study details as provided by Charsire Biotechnology Corp.:
Primary Outcome Measures:
- Incidence of complete ulcer closure during up to 12 weeks of treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
Secondary Outcome Measures:
- The ulcer closure time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Defined as the time to complete ulcer closure
- The half ulcer closure time (CT50) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Defined as the time to half ulcer closure
- The ulcer closure rate [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]The proportion of ulcer closure at each post-treatment visit
- Change from baseline in ulcer size [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]The ulcer size at each post-treatment visit minus the ulcer size at baseline
- Percentage change in ulcer size for each post-treatment visit [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]Calculated as (Ulcer size at post treatment visit - Ulcer size at baseline)/(Ulcer size at baseline)
Other Outcome Measures:
- Adverse event incidence [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12 ] [ Designated as safety issue: Yes ]
- Change in physical examination results [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ] [ Designated as safety issue: Yes ]
- Net change from baseline in laboratory test results [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ] [ Designated as safety issue: Yes ]
- Net change from baseline in vital signs [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CSTC1
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
Drug: CSTC1
vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof
|
|
Placebo Comparator: CSTC1 Matched vehicle
Matched vehicle, topical, two times daily
|
Drug: CSTC1 Matched vehicle |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01813305
Contacts
| Contact: Shr-Wei Chen, MS | 886-2-23810366 ext 103 | douglas-chen@tw.asklep.com |
Locations
| Taiwan | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Not yet recruiting |
| Kaohsiung, Taiwan | |
| Contact: Su-Shin Lee, MD 886-7-3208176 sushin@kmu.edu.tw | |
Sponsors and Collaborators
Charsire Biotechnology Corp.
ASKLEP Inc.
Investigators
| Principal Investigator: | Su-Shin Lee, MD | Kaohsiung Medical University Chung-Ho Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Charsire Biotechnology Corp. |
| ClinicalTrials.gov Identifier: | NCT01813305 History of Changes |
| Other Study ID Numbers: | CSTC1-01 |
| Study First Received: | March 12, 2013 |
| Last Updated: | March 13, 2013 |
| Health Authority: | Taiwan : Food and Drug Administration Taiwan: Institutional Review Board |
Keywords provided by Charsire Biotechnology Corp.:
|
Diabetic Foot Ulcer Diabetes Mellitus Debridement Standard of Care wounds |
Additional relevant MeSH terms:
|
Diabetic Foot Diabetes Mellitus Ulcer Foot Ulcer Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes Foot Diseases |
Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetic Neuropathies |
ClinicalTrials.gov processed this record on June 17, 2013