CSTC1 for Diabetic Foot Ulcers Phase II Study

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

Detailed Description
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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.

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

Conditions
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Diabetic Foot Ulcer, Diabetes Mellitus, Wounds

Intervention / Treatment
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* Drug: CSTC1
* Drug: CSTC1 Matched vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CSTC1<br>CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily | Drug: CSTC1<br>* vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof<br>|
| Placebo Comparator: CSTC1 Matched vehicle<br>Matched vehicle, topical, two times daily | Drug: CSTC1 Matched vehicle<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Standard of Care, wounds