CSTC1 for Diabetic Foot Ulcers Phase II Study

A Randomized,Double-Blind,Vehicle-controlled,Parallel,Phase II Study to Evaluate Efficacy and Safety of CSTC1 in Patient With Diabetic Foot Ulcers

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetic Foot Ulcer; Wounds
• Intervention / Treatment: Drug: CSTC1; Drug: CSTC1 Matched vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Ulcer Closure Time	Defined as the time to complete ulcer closure.	24 weeks
The Accumulated Participant Counts With Complete Ulcer Closure	Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements observed for at the last two consecutive study visits 2 weeks apart. The count of participants with complete ulcer closure at each post-treatment visit is provided.	24 weeks
Percentage Change in Ulcer Size for Each Post-treatment Visit	The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). This proportion was then multiplied by 100 to calculate the percentage change in ulcer size for each post-treatment visit. The percentage change in ulcer size for each post-treatment visit are presented.	baseline and 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication, whether or not related to the study medication. AE data was collected from Screening visit to Final visit (up to 24 weeks).	24 weeks
Number of Participants With Physical Abnormality Finding at the Visits	Physical examinations in this study included the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, joints, chest and lungs, abdomen, lymph nodes, musculoskeletal, nervous system, and others. Physical examinations were conducted from Screening visit to Final visit (up to 24 weeks). If at least one of physical examinations was identified in the subject, the subject was included in physical abnormalities calculation.	24 weeks
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline	Laboratory examination to be measured in this study consisted of hematology (hemoglobin, hematocrit, RBC, platelet, WBC with differential counts) and biochemistry (Aspartate Transaminase (AST), Alanine Transaminase (ALT), fasting glucose, HbA1c, serum creatinine, blood urea nitrogen (BUN), albumin). The laboratory examinations were conducted at the Screening visit, baseline, and Week 12. Patients' laboratory change from baseline to Week 12 was documented as relieved, unchanged, worsened (MH), or worsened (AE). The "worsened" means that the laboratory values were normal or non clinically significant (NCS) at baseline but change to clinically significant at Week 12. If the worsen situation was found, the clinically significant worsening changes were classified as related to medical history (MH) or adverse events (AE).	baseline and 12 weeks
Blood Pressure Change From Baseline to Week 24	Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, blood pressure (systolic/diastolic) were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).	baseline and 24 weeks
Pulse Rate Change From Baseline to Week 24	Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, pulse rates were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).	baseline and 24 weeks
Body Temperature Change From Baseline to Week 24	Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, body temperature were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).	baseline and 24 weeks
Respiratory Rate Change From Baseline to Week 24	Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, respiratory rate were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).	baseline and 24 weeks

Collaborators and Investigators

• Sponsor: Charsire Biotechnology Corp.
• Collaborators: ASKLEP Inc.
• Investigators: Principal Investigator: Su-Shin Lee, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2014
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 13, 2013
• First Posted (Estimate): March 18, 2013

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Standard of Care; Diabetic Foot Ulcer; wounds; Debridement
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetic Neuropathies; Foot Diseases; Diabetes Mellitus; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: CSTC1-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No