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CSTC1 for Diabetic Foot Ulcers Phase II Study

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ClinicalTrials.gov Identifier: NCT01813305
Recruitment Status : Recruiting
First Posted : March 18, 2013
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
ASKLEP Inc.
Information provided by (Responsible Party):
Charsire Biotechnology Corp.

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetes Mellitus Wounds Drug: CSTC1 Drug: CSTC1 Matched vehicle Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence of complete ulcer closure during up to 12 weeks of treatment period [ Time Frame: 12 weeks ]
    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 :
  1. The ulcer closure time [ Time Frame: 12 weeks ]
    Defined as the time to complete ulcer closure

  2. The half ulcer closure time (CT50) [ Time Frame: 12 weeks ]
    Defined as the time to half ulcer closure

  3. The ulcer closure rate [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12 ]
    The proportion of ulcer closure at each post-treatment visit

  4. Change from baseline in ulcer size [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ]
    The ulcer size at each post-treatment visit minus the ulcer size at baseline

  5. Percentage change in ulcer size for each post-treatment visit [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ]
    Calculated as (Ulcer size at post treatment visit - Ulcer size at baseline)/(Ulcer size at baseline)


Other Outcome Measures:
  1. Adverse event incidence [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12 ]
  2. Change in physical examination results [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ]
  3. Net change from baseline in laboratory test results [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ]
  4. Net change from baseline in vital signs [ Time Frame: Baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813305


Contacts
Contact: Shr-Wei Chen, MS 886-2-2365-0660 ext 301 douglas-chen@a2healthcare.com

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital 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

Responsible Party: Charsire Biotechnology Corp.
ClinicalTrials.gov Identifier: NCT01813305     History of Changes
Other Study ID Numbers: CSTC1-01
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Charsire Biotechnology Corp.:
Diabetic Foot Ulcer
Diabetes Mellitus
Debridement
Standard of Care
wounds

Additional relevant MeSH terms:
Foot Diseases
Diabetes Mellitus
Ulcer
Diabetic Foot
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies