CSTC1 for Diabetic Foot Ulcers Phase II Study

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813305
• Other study ID #: CSTC1-01
• Status: Completed
• Phase: Phase 2
• Start date: July 9, 2014
• Est. completion date: January 7, 2020

Study information

• Verified date: February 2022
• Source: Charsire Biotechnology Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 7, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer
• Wounds

Intervention

Drug:
• CSTC1
vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof
• CSTC1 Matched vehicle

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Charsire Biotechnology Corp.	ASKLEP Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	The Ulcer Closure Time	Defined as the time to complete ulcer closure.	24 weeks
Secondary	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
Secondary	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