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CSTC1 for Diabetic Foot Ulcers Phase II Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Charsire Biotechnology Corp.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 24, 2014