CSTC1 for Diabetic Foot Ulcers Phase II Study

NCT ID: NCT01813305

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-09
• Study Completion Date: 2020-01-07

Brief Summary

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

Detailed Description

This study was designed as a randomized, double-blind, vehicle-controlled, multiple-center, and parallel trial to evaluate the efficacy and safety of CSTC1 in patients with diabetic foot ulcers (DFU). In each study site, eligible patients were randomized in a 4:1 ratio to receive either one of the topical applications of CSTC1 or CSTC1 matched vehicle, topical application on target diabetic foot ulcer (DFU), 2 times daily.

The treatment duration for each subject was 12 weeks or up to confirmed complete ulcer closure, whichever comes first. That was, subjects would receive treatment for at most 12 weeks, which consists of 8 visits located at weeks 1, 2, 3, 4, 6, 8, 10, and 12. Subjects who achieved confirmed complete ulcer closure during the treatment period would be arranged for a 12 week post-treatment follow-up. Subjects failed to achieve complete ulcer closure at week-12 visit would be arranged for 4 weeks of safety follow-up. If confirmation of complete ulcer closure was reached at a week-14 visit, the subject would continue the post-treatment follow-up visit until week-24 visit. Otherwise, the subject would be arranged for safety follow-up until week-16 visit.

Conditions

Diabetic Foot Ulcer; Diabetes Mellitus; Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CSTC1

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

Group Type: ACTIVE_COMPARATOR

CSTC1

Intervention Type: DRUG

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

CSTC1 Matched vehicle

Matched vehicle, topical, two times daily

Group Type: PLACEBO_COMPARATOR

CSTC1 Matched vehicle

Intervention Type: DRUG

Interventions

CSTC1

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

Intervention Type: DRUG

CSTC1 Matched vehicle

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ASKLEP Inc.

INDUSTRY

Sponsor Role: collaborator

Charsire Biotechnology Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Su-Shin Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CSTC1-01

Identifier Type: -

Identifier Source: org_study_id