CSTC1 for Diabetic Foot Ulcers Phase II Study

• Sponsor: Charsire Biotechnology Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01813305
• Collaborator: ASKLEP Inc. (Industry)
• Enrollment: 124
• Location: 1
• Arms: 2
• Actual Duration (Months): 66
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer; Diabetes Mellitus; Wounds	Drug: CSTC1; Drug: CSTC1 Matched vehicle	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 9, 2014
• Actual Primary Completion Date: Jan 7, 2020
• Actual Study Completion Date: Jan 7, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Complete Ulcer Closure During the Treatment Period [Baseline to 14 weeks]

   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

1. The Ulcer Closure Time [24 weeks]

   Defined as the time to complete ulcer closure.

2. The Accumulated Participant Counts With Complete Ulcer Closure [24 weeks]

   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.

3. Percentage Change in Ulcer Size for Each Post-treatment Visit [baseline and 24 weeks]

   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.

Other Outcome Measures

1. Number of Participants With Adverse Events [24 weeks]

   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).

2. Number of Participants With Physical Abnormality Finding at the Visits [24 weeks]

   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.

3. Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline [baseline and 12 weeks]

   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).

4. Blood Pressure Change From Baseline to Week 24 [baseline and 24 weeks]

   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).

5. Pulse Rate Change From Baseline to Week 24 [baseline and 24 weeks]

   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).

6. Body Temperature Change From Baseline to Week 24 [baseline and 24 weeks]

   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).

7. Respiratory Rate Change From Baseline to Week 24 [baseline and 24 weeks]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan

Sponsors and Collaborators

• Charsire Biotechnology Corp.
• ASKLEP Inc.

Investigators

• Principal Investigator: Su-Shin Lee, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 23, 2017

More Information

Publications

None provided.

• Responsible Party: Charsire Biotechnology Corp.
• ClinicalTrials.gov Identifier: NCT01813305
• Other Study ID Numbers: CSTC1-01
• First Posted: Mar 18, 2013
• Last Update Posted: Apr 12, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Charsire Biotechnology Corp.: Diabetic Foot Ulcer; Diabetes Mellitus; Debridement; Standard of Care; wounds
• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer; Diabetes Mellitus; Ulcer

Study Results

Participant Flow

Pre-assignment Detail

The planned sample size was determined to be 80 versus 20 subjects (4:1 ratio) for treatment versus vehicle groups, 100 subjects in total. To ensure the completion of 100 evaluable subjects, around 125 subjects were planned to be recruited. In the actual trial, a total of 137 subjects were screened, with 124 meeting the criteria followed by randomization to CSTC1 group (n = 98) or Vehicle group (n = 26).

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Period Title: Overall Study
STARTED	98	26
COMPLETED	63	18
NOT COMPLETED	35	8

Baseline Characteristics

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle	Total
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily	Total of all reporting groups
Overall Participants	98	26	124
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.1 (13.79)	58.6 (11.84)	58.2 (13.36)
Sex: Female, Male (Count of Participants)
Female	67 68.4%	17 65.4%	84 67.7%
Male	31 31.6%	9 34.6%	40 32.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Taiwan	98 100%	26 100%	124 100%
Baseline Diabetic Foot Target Ulcer Size (Count of Participants)
> 1 ~ 1.5 cm^2	27 27.6%	5 19.2%	32 25.8%
> 1.5 ~ 2 cm^2	11 11.2%	4 15.4%	15 12.1%
> 2 ~ 3 cm^2	15 15.3%	4 15.4%	19 15.3%
> 3 ~ 4 cm^2	14 14.3%	2 7.7%	16 12.9%
> 4 ~ 5 cm^2	8 8.2%	4 15.4%	12 9.7%
> 5 ~ 10 cm^2	15 15.3%	4 15.4%	19 15.3%
> 10 ~ 15 cm^2	4 4.1%	1 3.8%	5 4%
> 15 ~ 20 cm^2	2 2%	1 3.8%	3 2.4%
> 20 cm^2	2 2%	1 3.8%	3 2.4%
Maximum Grade of Foot Ulcers (Count of Participants)
Grade 1	15 15.3%	4 15.4%	19 15.3%
Grade 2	83 84.7%	22 84.6%	105 84.7%
Baseline Target Ulcer Size (cm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm^2]	4.37 (5.471)	5.15 (5.531)	4.53 (5.470)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized subjects who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Count of Participants [Participants]	32 32.7%	4 15.4%

2. Secondary Outcome

Title	The Ulcer Closure Time
Description	Defined as the time to complete ulcer closure.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

All randomized subjects who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Mean (Standard Error) [Days]	87 (2.2)	92 (3.2)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Week 1	0 0%	0 0%
Week 2	0 0%	0 0%
Week 3	0 0%	0 0%
Week 4	0 0%	0 0%
Week 6	2 2%	1 3.8%
Week 8	9 9.2%	1 3.8%
Week 10	13 13.3%	1 3.8%
Week 12	22 22.4%	2 7.7%
Week 14	32 32.7%	4 15.4%
Week 16	35 35.7%	7 26.9%
Week 20	35 35.7%	7 26.9%
Week 24	36 36.7%	6 23.1%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Week 1	-15.2 (28.31)	-16.3 (25.09)
Week 2	-28.3 (30.32)	-21.7 (32.82)
Week 3	-36.3 (34.93)	-29.1 (41.00)
Week 4	-46.6 (35.15)	-32.8 (36.90)
Week 6	-53.6 (40.13)	-44.8 (41.11)
Week 8	-56.7 (49.96)	-47.0 (46.67)
Week 10	-61.7 (47.01)	-51.8 (44.85)
Week 12	-66.3 (41.91)	-54.2 (56.52)
Week 14	-69.1 (39.09)	-57.6 (57.54)
Week 16	-69.8 (38.40)	-59.1 (60.05)
Week 20	-70.4 (38.60)	-59.1 (60.05)
Week 24	-70.2 (38.52)	-59.0 (59.95)

5. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Count of Participants [Participants]	80 81.6%	22 84.6%

6. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Baseline (Day 1)	57 58.2%	18 69.2%
Week 1	57 58.2%	18 69.2%
Week 2	57 58.2%	18 69.2%
Week 3	59 60.2%	16 61.5%
Week 4	57 58.2%	16 61.5%
Week 6	57 58.2%	17 65.4%
Week 8	52 53.1%	16 61.5%
Week 10	45 45.9%	16 61.5%
Week 12	41 41.8%	16 61.5%
Week 14	43 43.9%	12 46.2%
Week 16	42 42.9%	12 46.2%
Week 20	18 18.4%	2 7.7%
Week 24	15 15.3%	2 7.7%

7. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Relieved	0 0%	0 0%
Unchanged	81 82.7%	22 84.6%
Worsened (MH)	2 2%	0 0%
Worsened (AE)	5 5.1%	0 0%
Relieved	0 0%	0 0%
Unchanged	84 85.7%	22 84.6%
Worsened (MH)	2 2%	0 0%
Worsened (AE)	1 1%	0 0%
Relieved	0 0%	0 0%
Unchanged	87 88.8%	22 84.6%
Worsened (MH)	0 0%	0 0%
Worsened (AE)	0 0%	0 0%
Relieved	0 0%	0 0%
Unchanged	87 88.8%	22 84.6%
Worsened (MH)	0 0%	0 0%
Worsened (AE)	0 0%	0 0%
Relieved	0 0%	0 0%
Unchanged	83 84.7%	22 84.6%
Worsened (MH)	2 2%	0 0%
Worsened (AE)	2 2%	0 0%
Relieved	0 0%	0 0%
Unchanged	87 88.8%	22 84.6%
Worsened (MH)	0 0%	0 0%
Worsened (AE)	0 0%	0 0%
Relieved	2 2%	0 0%
Unchanged	81 82.7%	21 80.8%
Worsened (MH)	5 5.1%	1 3.8%
Worsened (AE)	0 0%	0 0%
Relieved	3 3.1%	0 0%
Unchanged	80 81.6%	21 80.8%
Worsened (MH)	5 5.1%	1 3.8%
Worsened (AE)	0 0%	0 0%
Relieved	2 2%	0 0%
Unchanged	82 83.7%	21 80.8%
Worsened (MH)	4 4.1%	1 3.8%
Worsened (AE)	0 0%	0 0%
Relieved	0 0%	0 0%
Unchanged	86 87.8%	22 84.6%
Worsened (MH)	2 2%	0 0%
Worsened (AE)	0 0%	0 0%
Relieved	5 5.1%	0 0%
Unchanged	79 80.6%	21 80.8%
Worsened (MH)	4 4.1%	1 3.8%
Worsened (AE)	0 0%	0 0%
Relieved	1 1%	0 0%
Unchanged	85 86.7%	22 84.6%
Worsened (MH)	1 1%	0 0%
Worsened (AE)	0 0%	0 0%
Relieved	1 1%	0 0%
Unchanged	86 87.8%	22 84.6%
Worsened (MH)	1 1%	0 0%
Worsened (AE)	0 0%	0 0%
Relieved	6 6.1%	2 7.7%
Unchanged	77 78.6%	19 73.1%
Worsened (MH)	5 5.1%	1 3.8%
Worsened (AE)	0 0%	0 0%
Relieved	6 6.1%	1 3.8%
Unchanged	78 79.6%	21 80.8%
Worsened (MH)	4 4.1%	0 0%
Worsened (AE)	0 0%	0 0%
Relieved	13 13.3%	1 3.8%
Unchanged	66 67.3%	18 69.2%
Worsened (MH)	9 9.2%	3 11.5%
Worsened (AE)	0 0%	0 0%

8. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Systolic Blood Pressure [mmHg]	-3.67 (27.088)	-20.00 (34.137)
Diastolic Blood Pressure [mmHg]	1.41 (13.882)	-6.25 (4.646)

9. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily CSTC1: vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof	Matched vehicle, topical, two times daily CSTC1 Matched vehicle
Measure Participants	27	4
Mean (Standard Deviation) [beats/min]	4.00 (9.899)	-1.25 (9.323)

10. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily CSTC1: vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof	Matched vehicle, topical, two times daily CSTC1 Matched vehicle
Measure Participants	27	4
Mean (Standard Deviation) [degrees Celsius]	0.08 (0.468)	0.33 (0.377)

11. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily CSTC1: vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof	Matched vehicle, topical, two times daily CSTC1 Matched vehicle
Measure Participants	27	4
Mean (Standard Deviation) [breaths/min]	-0.11 (1.672)	-3.25 (3.862)

12. Post-Hoc Outcome

Title	Time to Achieve ≥ 50% Reduction in Target Ulcer Size
Description	The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). Time to achieve ≥ 50% reduction in target ulcer size was measured from Screening visit to Final visit (up to 24 weeks).
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Mean (Standard Deviation) [Days]	42 (3.3)	52 (7.1)

13. Post-Hoc Outcome

Title	The Response Rate of the Target Ulcer Size Reduction ≥ 50%
Description	The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). A subject who had target ulcer closure ≥ 50% was counted as a responder. The non-responders included subjects whose target ulcer closure size less than 50% before 12 weeks.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Responder	77 78.6%	18 69.2%
Non-Responder	21 21.4%	8 30.8%

14. Post-Hoc Outcome

Title	Time to Achieve ≥90% Reduction in Target Ulcer Size
Description	The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). Time to achieve ≥ 90% reduction in target ulcer size was analyzed in the subjects.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Mean (Standard Deviation) [Days]	73 (2.9)	84 (4.4)

15. Post-Hoc Outcome

Title	The Response Rate of the Target Ulcer Size Reduction ≥ 90%
Description	Subjects with ulcer closure size ≥ 90% compared to the baseline at a Week 12 were considered as a responder. A subject whose target ulcer size reduction was less than 90% was counted as a non-responder. The percentage of repsonders and non-responders were presented.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

All randomized patients who have received at least one dose of study medication.

Arm/Group Title	CSTC1	CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily	Matched vehicle, topical, two times daily
Measure Participants	98	26
Responder	49 50%	12 46.2%
Non-Responder	49 50%	14 53.8%

Adverse Events

Time Frame	AE data was collected from Screening visit to Final visit (up to 24 weeks)
Adverse Event Reporting Description	All enrolled subjects were used for the analysis of AE and SAE
Arm/Group Title	CSTC1		CSTC1 Matched Vehicle
Arm/Group Description	CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily		Matched vehicle, topical, two times daily
All Cause Mortality
	CSTC1		CSTC1 Matched Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/98 (2%)		1/26 (3.8%)
Serious Adverse Events
	CSTC1		CSTC1 Matched Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/98 (20.4%)		3/26 (11.5%)
Cardiac disorders
Acute myocardial infarction	1/98 (1%)	1	0/26 (0%)	0
Cardiac arrest	1/98 (1%)	1	0/26 (0%)	0
General disorders
Impaired healing	1/98 (1%)	1	0/26 (0%)	0
Infections and infestations
Cellulitis	5/98 (5.1%)	5	1/26 (3.8%)	1
Abdominal sepsis	1/98 (1%)	1	0/26 (0%)	0
Wound sepsis	1/98 (1%)	1	0/26 (0%)	0
Diabetic gangrene	1/98 (1%)	1	0/26 (0%)	0
Pulmonary sepsis	1/98 (1%)	1	0/26 (0%)	0
Application site cellulitis	2/98 (2%)	2	0/26 (0%)	0
Pyelonephritis acute	1/98 (1%)	1	0/26 (0%)	0
Osteomyelitis	1/98 (1%)	1	1/26 (3.8%)	1
Streptococcal sepsis	1/98 (1%)	1	0/26 (0%)	0
Sepsis	1/98 (1%)	1	0/26 (0%)	0
Septic shock	1/98 (1%)	1	0/26 (0%)	0
Bacteraemia	0/98 (0%)	0	1/26 (3.8%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/98 (1%)	1	0/26 (0%)	0
Nervous system disorders
Orthostatic hypotension	1/98 (1%)	1	0/26 (0%)	0
Renal and urinary disorders
Nephrolithiasis	1/98 (1%)	1	0/26 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory failure	0/98 (0%)	0	1/26 (3.8%)	1
Vascular disorders
Peripheral arterial occlusive disease	1/98 (1%)	1	0/26 (0%)	0
Other (Not Including Serious) Adverse Events
	CSTC1		CSTC1 Matched Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/98 (44.9%)		13/26 (50%)
Eye disorders
Cataract	5/98 (5.1%)	5	0/26 (0%)	0
General disorders
Application site erosion	6/98 (6.1%)	7	0/26 (0%)	0
Peripheral swelling	4/98 (4.1%)	4	2/26 (7.7%)	2
Infections and infestations
Nasopharyngitis	7/98 (7.1%)	7	2/26 (7.7%)	2
Injury, poisoning and procedural complications
Limb injury	17/98 (17.3%)	31	7/26 (26.9%)	12
Skin abrasion	5/98 (5.1%)	5	1/26 (3.8%)	1
Wound complication	2/98 (2%)	2	2/26 (7.7%)	2
Skin wound	2/98 (2%)	2	2/26 (7.7%)	2
Respiratory, thoracic and mediastinal disorders
Cough	6/98 (6.1%)	6	0/26 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.