CSTC1 for Diabetic Foot Ulcers Phase II Study

NCT01813305 | Completed Phase 2 Results

• 1 other identifier: CSTC1-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot Ulcer; Diabetes Mellitus; Wounds

Keywords

Diabetic Foot Ulcer; Diabetes Mellitus; Debridement; Standard of Care; wounds

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Ulcer Closure During the Treatment Period

  Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at the coming visits 2 weeks apart. The treatment period is until 12 weeks or up to confirmation of complete ulcer closure. Subjects with complete ulcer closure at Week 12 and confirmed at Week 14 were considered as success.

  Baseline to 14 weeks

Secondary Outcomes (3)

• The Ulcer Closure Time

  24 weeks

• The Accumulated Participant Counts With Complete Ulcer Closure

  24 weeks

• Percentage Change in Ulcer Size for Each Post-treatment Visit

  baseline and 24 weeks

Other Outcomes (7)

• Number of Participants With Adverse Events

  24 weeks

• Number of Participants With Physical Abnormality Finding at the Visits

  24 weeks

• Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline

  baseline and 12 weeks

Study Arms (2)

CSTC1

ACTIVE COMPARATOR

CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily

Drug: CSTC1

CSTC1 Matched vehicle

PLACEBO COMPARATOR

Matched vehicle, topical, two times daily

Drug: CSTC1 Matched vehicle

Interventions

CSTC1 DRUG

vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof

CSTC1

CSTC1 Matched vehicle DRUG

CSTC1 Matched vehicle

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charsire Biotechnology Corp.: lead
• ASKLEP Inc.: collaborator

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: R&D associate
• Organization: Charsire Biotechnology Corp.

cs42@charsire.com

+886-6-702-0817

Study Officials

• Su-Shin Lee, MD

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 18, 2013
• Study Start: July 9, 2014
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)