Back to resultsCSTC1 for Diabetic Foot Ulcers Phase II Study
Primary Purpose
Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
CSTC1
CSTC1 Matched vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Standard of Care, wounds
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.
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CSTC1
CSTC1 Matched vehicle
Arm Description
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
Matched vehicle, topical, two times daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The Ulcer Closure Time
Defined as the time to complete ulcer closure.
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.
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.
Full Information
NCT ID
NCT01813305
First Posted
March 12, 2013
Last Updated
February 14, 2022
Sponsor
Charsire Biotechnology Corp.
Collaborators
ASKLEP Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01813305
Brief Title
CSTC1 for Diabetic Foot Ulcers Phase II Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2014 (Actual)
Primary Completion Date
January 7, 2020 (Actual)
Study Completion Date
January 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charsire Biotechnology Corp.
Collaborators
ASKLEP Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
Keywords
Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Standard of Care, wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CSTC1
Arm Type
Active Comparator
Arm Description
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
Arm Title
CSTC1 Matched vehicle
Arm Type
Placebo Comparator
Arm Description
Matched vehicle, topical, two times daily
Intervention Type
Drug
Intervention Name(s)
CSTC1
Intervention Description
vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof
Intervention Type
Drug
Intervention Name(s)
CSTC1 Matched vehicle
Primary Outcome Measure Information:
Title
Number of Participants With Complete Ulcer Closure During the Treatment Period
Description
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.
Time Frame
Baseline to 14 weeks
Secondary Outcome Measure Information:
Title
The Ulcer Closure Time
Description
Defined as the time to complete ulcer closure.
Time Frame
24 weeks
Title
The Accumulated Participant Counts With Complete Ulcer Closure
Description
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.
Time Frame
24 weeks
Title
Percentage Change in Ulcer Size for Each Post-treatment Visit
Description
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.
Time Frame
baseline and 24 weeks
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events
Description
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).
Time Frame
24 weeks
Title
Number of Participants With Physical Abnormality Finding at the Visits
Description
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.
Time Frame
24 weeks
Title
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Description
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).
Time Frame
baseline and 12 weeks
Title
Blood Pressure Change From Baseline to Week 24
Description
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).
Time Frame
baseline and 24 weeks
Title
Pulse Rate Change From Baseline to Week 24
Description
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).
Time Frame
baseline and 24 weeks
Title
Body Temperature Change From Baseline to Week 24
Description
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).
Time Frame
baseline and 24 weeks
Title
Respiratory Rate Change From Baseline to Week 24
Description
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).
Time Frame
baseline and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-Shin Lee, MD
Organizational Affiliation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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CSTC1 for Diabetic Foot Ulcers Phase II Study
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