Diabetic Foot UlcerPhase 2NCT01813305
CSTC1 for Diabetic Foot Ulcers Phase II Study
A Phase 2 study testing CSTC1 in people with Diabetic Foot Ulcer and Diabetes Mellitus, run by Charsire Biotechnology Corp. at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
- What is being tested?
- CSTC1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jul 2014to 7 Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this 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
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
Read the 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.
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
- Being tested
- CSTC1, CSTC1 Matched vehicle
- Keywords
- Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Standard of Care, wounds
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSTC1Drug
vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof
CSTC1 Matched vehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| CSTC1 | Active comparator | CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily Receives: Drug: CSTC1 |
| CSTC1 Matched vehicle | Placebo comparator | Matched vehicle, topical, two times daily Receives: Drug: CSTC1 Matched vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 14 weeks
Secondary outcomes (3)
The Ulcer Closure Time
Defined as the time to complete ulcer closure.
Measured: 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.
Measured: 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.
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study start9 Jul 2014
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charsire Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ASKLEP Inc.
- Responsible party
- Sponsor
- Investigators
- Su-Shin Lee, MD, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813305
- Sponsor's protocol ID
- CSTC1-01
- Status last verified
- Feb 2022
- First submitted
- 12 Mar 2013
- Last updated
- 12 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01813305
- Acronym / sponsor ID
- CSTC1-01
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
- Keywords
- Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Standard of Care, wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Charsire Biotechnology Corp.Industry (pharma, biotech, devices)
- Collaborators
- ASKLEP Inc.
- Study start
- 9 Jul 2014 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Posted 12 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSTC1 | Active comparator | Drug: CSTC1CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily |
| CSTC1 Matched vehicle | Placebo comparator | Drug: CSTC1 Matched vehicleMatched vehicle, topical, two times daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSTC1vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof | Drug | CSTC1 |
| CSTC1 Matched vehicle | Drug | CSTC1 Matched vehicle |
Primary outcome
Number of Participants With Complete Ulcer Closure During the Treatment Period
Time frame: 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.
3 secondary outcomes
The Ulcer Closure Time
Time frame: 24 weeks
The Accumulated Participant Counts With Complete Ulcer Closure
Time frame: 24 weeks
Percentage Change in Ulcer Size for Each Post-treatment Visit
Time frame: baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su-Shin Lee, MD principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CSTC1 in people with Diabetic Foot Ulcer and Diabetes Mellitus, run by Charsire Biotechnology Corp. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Ulcer Closure During the Treatment Period (time frame: Baseline to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.