Chronic Limb-Threatening IschemiaPhase 3CIRCLE-AsiaNCT07536373
Colchicine in Chronic Limb-Threatening Ischemia
A Phase 3 study testing Colchicine 0.5 MG Oral Tablet Once Daily in people with Chronic Limb-Threatening Ischemia, run by Shin Kong Wu Ho-Su Memorial Hospital at 5 sites in Taiwan.
Trial summary
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, a condition in which narrowed or blocked arteries reduce blood flow to the legs. People with CLTI may have severe leg pain at rest, non-healing wounds, or gangrene, and face a high risk of leg amputation and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb-Threatening Ischemia
- What is being tested?
- Colchicine 0.5 MG Oral Tablet Once Daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesTaiwan
- Study dates
- 2 Jun 2026to Apr 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Documented chronic limb-threatening ischemia, meeting the following:
- Presence of ischemic symptoms compatible with CLTI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford classes 4-5 AND
- Imaging evidence within the past 12 months showing atherosclerotic PAD, including CTA, MRA, angiography or duplex ultrasound AND
- Ankle-Brachial Index (ABI) ≤0.80 or Toe-Brachial Index (TBI) ≤0.60 for patients without prior revascularization; ABI ≤0.85 or TBI ≤0.65 for those with prior revascularization OR
- Ischemic rest pain alone (Rutherford class 4) defined as ankle systolic pressure <50 mmHg, toe pressure of <30 mmHg, transcutaneous PO2 of <30 mmHg, or flat-line transtarsal pulse volume recording OR
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- Tissue loss with or without ischemic rest pain (Rutherford class 5) defined as ankle systolic pressure <70 mmHg, toe pressure of <50 mmHg, transcutaneous PO2 of <30 mmHg, or flatline transtarsal pulse volume recording
- Recent successful revascularization:
- Underwent technically successful endovascular therapy (EVT) or surgical bypass within the last 7 days prior to randomization
- For individuals requiring multiple revascularization attempts on the same index leg, the procedure considered for eligibility (in other words, the qualifying or index procedure) must be the final planned or anticipated revascularization attempt
- There must be demonstrated graft or vascular patency after the qualifying revascularization procedure with one in-line blood flow to the foot, either by angiography, duplex ultrasound, CTA or MRA
- There must be no immediate plan for reintervention
- Informed Consent:
- Demonstrated ability and willingness to adhere to the study protocol, attend scheduled follow-up visits, complete all required assessments, and provide written informed consent
Who cannot join
- Age <18 years
- Asymptomatic or mild disease: Patients who underwent revascularization for disease graded Rutherford classes 0-3
- Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening
- Failure to establish at least one tibial artery outflow after revascularization
- Recent acute limb ischemia events within 2 weeks of screening
- Clinical signs of active, uncontrolled, severe limb infection or septicemia, such as fever exceeding 38.5°C, a white blood cell count above 15,000 cells/µL, or hypotension, at the time of screening (this does not include osteomyelitis confined to the phalanges or metatarsal heads or foot cellulitis treatable with IV antibiotics at the time of revascularization)
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- Unstable hemodynamics after the index revascularization procedure
- Unable to tolerate any antiplatelet agent or with severe bleeding diathesis
- Acute coronary syndrome, acute stroke, or hospitalization for heart failure within 30 days of screening
- Any contraindication or known intolerance to colchicine
- Requirement for colchicine for another indication
- Need for use of medications known to have drug-drug interactions with colchicine, particularly drugs known to inhibit CYP3A4 or P-glycoprotein
- Active hepatitis or severe liver cirrhosis (Child Pugh C)
- Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
- Previous (within 30 days) or concomitant participation in another clinical study with investigational medicinal product(s)
- Life expectancy <1 year
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Not yet recruiting
Chi Mei Medical Center
Tainan, 710
Chon-Seng Hong, MD, +886-6-281-2811, Ahsingsing@gmail.com
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taipei, 111
Donna SH Lin, MD, +886-2-2833-2211, donna.lin24@gmail.com
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jen-Kuang Lee, MD, PhD, +886-2-2312-3456, b85401104@gmail.com
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, 112
Tai-Wei Chen, MD, +886-2-2871-2121, radiant107@gmail.com
- Not yet recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
Chun-Chi Chen, MD, +886-3-328-1200, mr3228@gmail.com
About this study
Official title: Colchicine in Chronic Limb-Threatening Ischemia for Reduction of Complications and Limb Events in Asia
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, a condition in which narrowed or blocked arteries reduce blood flow to the legs. People with CLTI may have severe leg pain at rest, non-healing wounds, or gangrene, and face a high risk of leg amputation and death. Even after successful procedures to restore blood flow to the leg (called revascularization), many patients still experience serious complications. Inflammation in the blood vessels is believed to play an important role in these poor outcomes.
Colchicine is an anti-inflammatory medication that has been used safely for decades to treat gout and other inflammatory conditions. Recent large clinical trials have shown that a low dose of colchicine (0.5 mg per day) can reduce heart attacks and strokes in patients with coronary artery disease. However, it has not been studied in patients with CLTI.
Read more
The CIRCLE-Asia trial (Colchicine in Chronic Limb-Threatening Ischemia for Reduction of Complications and Limb Events in Asia) is a pilot study designed to evaluate whether colchicine can improve outcomes in patients with CLTI who have recently undergone a successful procedure to restore blood flow to their leg. Treatment begins within 7 days of the procedure.
This is a randomized, double-blind, placebo-controlled, multicenter trial conducted at five hospitals in Taiwan. A total of 200 adult patients with CLTI who have undergone successful revascularization will be randomly assigned in a 1:1 ratio to receive either colchicine 0.5 mg once daily or a matching placebo pill, in addition to their usual medications, for 12 months. Neither the patients nor the study doctors will know which treatment each patient receives.
The main outcome of interest is amputation-free survival, defined as the time until major amputation of the affected leg (above the ankle) or death from any cause, over 12 months of follow-up. The study will also assess other important outcomes including major limb complications, heart attacks, strokes, wound healing, changes in blood flow measurements, inflammatory blood markers, quality of life, and medication safety.
This pilot trial will provide the first randomized evidence on the potential benefits and safety of colchicine in CLTI patients and will help inform the design of a larger definitive trial.
- Conditions
- Chronic Limb-Threatening Ischemia
- Being tested
- Colchicine 0.5 MG Oral Tablet Once Daily, Placebo
- Keywords
- CIRCLE-Asia, Chronic limb-threatening ischemia, Peripheral artery disease, Colchicine, Amputation-free survival
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MG Oral Tablet Once DailyDrug
Colchicine 0.5 mg oral tablet (Colchicine Tablets 0.5mg, Synmosa), taken once daily in addition to standard of care, for 12 months. Treatment is initiated within 7 days of successful lower-extremity revascularization. For patients experiencing intolerance such as diarrhea or gastrointestinal discomfort, the dose may be reduced to 0.25 mg daily (half tablet). If the medication is considered harmful, treatment is interrupted and resumed when safe.
PlaceboDrug
Matching placebo tablet, identical in appearance to the colchicine 0.5 mg tablet (supplied by Synmosa Biopharma Corporation), taken orally once daily in addition to standard of care, for 12 months. Treatment is initiated within 7 days of successful lower-extremity revascularization. The same dose adjustment and discontinuation rules apply as for the active treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Colchicine 0.5 mg per tab, taken 1 tab daily Receives: Drug: Colchicine 0.5 MG Oral Tablet Once Daily |
| Placebo | Placebo comparator | Placebo tablets matching in appearance with study drug, taken 1 tab per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation-free survival
Defined as the time to major (above the ankle) amputation of the study limb or death from any cause
Measured: 12 months
Secondary outcomes (19)
Number of Participants with Major (Above the Ankle) Non-Traumatic Amputation of the Study Limb
Number of participants who underwent major (above the ankle) non-traumatic amputation of the study limb during the 12-month follow-up period.
Measured: 12 months
Major adverse limb event (MALE, including non-traumatic above-ankle amputation and major lower limb artery reintervention) and its components
Measured: 12 months
Major adverse cardiovascular event (MACE, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) and its components
Measured: 12 months
Wound healing rates at 3, 6, 9 and 12 months for Rutherford 5 patients (or time to wound healing)
Measured: 12 months
Number of Participants with Acute Limb Ischemia
Number of participants experiencing acute limb ischemia of the study limb during the 12-month follow-up period, adjudicated by a blinded clinical events committee.
Measured: 12 months
Number of Deaths from Any Cause
Number of participants who died from any cause during the 12-month follow-up period.
Measured: 12 months
Number of Deaths from Cardiovascular Causes
Number of participants who died from cardiovascular causes during the 12-month follow-up period, adjudicated by a blinded clinical events committee.
Measured: 12 months
Number of Deaths from Limb-Related Causes
Number of participants who died from limb-related causes (e.g., fatal limb sepsis, complications of major amputation) during the 12-month follow-up period.
Measured: 12 months
Number of Participants with Adverse Gastrointestinal Events
Number of participants experiencing adverse gastrointestinal events (including nausea, vomiting, abdominal pain, and diarrhea) during the 12-month treatment period.
Measured: 12 months
Number of Participants with Adverse Hematologic Events
Number of participants experiencing adverse hematologic events (including leukopenia, thrombocytopenia, and anemia) during the 12-month treatment period.
Measured: 12 months
Number of Participants with Serious Infections
Number of participants experiencing serious infections (defined as infections requiring hospitalization or intravenous antibiotics) during the 12-month follow-up period.
Measured: 12 months
Number of Participants with Diarrhea
Number of participants experiencing diarrhea as an adverse event during the 12-month treatment period. Diarrhea is defined as the passage of three or more loose or watery stools within a 24-hour period, and severity is graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 = increase of <4 stools/day over baseline; Grade 2 = increase of 4-6 stools/day; Grade 3 = increase of ≥7 stools/day or hospitalization indicated; Grade 4 = life-threatening consequences; Grade 5 = death.
Measured: 12 months
Number of Participants with Drug Discontinuation Due to Any Adverse Event
Number of participants who permanently discontinued the study drug due to any adverse event during the 12-month treatment period.
Measured: 12 months
Change in Health-Related Quality of Life as Measured by the EQ-5D-5L Index Score
Change from baseline in EQ-5D-5L index score at 12 months. The EQ-5D-5L is a generic health status questionnaire. Index scores range from -0.6 to 1.0, where higher scores indicate better health-related quality of life.
Measured: Baseline and 12 months
Change in Disease-Specific Quality of Life as Measured by the VASCUQOL-6 Score
Change from baseline in Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) summary score at 12 months. VASCUQOL-6 scores range from 6 to 24, where higher scores indicate better vascular disease-specific quality of life.
Measured: Baseline and 12 months
Change in Walking Ability as Measured by the Walking Impairment Questionnaire (WIQ) Score
Change from baseline in Walking Impairment Questionnaire (WIQ) composite score at 12 months. The WIQ assesses walking distance, walking speed, and stair climbing. Each domain is scored from 0 to 100, where higher scores indicate better walking ability.
Measured: Baseline and 12 months
Change in Ankle-Brachial Index (ABI)
Change from baseline in ankle-brachial index (ABI) of the study limb at 12 months. ABI is calculated as the ratio of ankle systolic blood pressure to brachial systolic blood pressure (unitless ratio). Higher values indicate better lower-extremity arterial perfusion.
Measured: Baseline and 12 months
Change in Toe-Brachial Index (TBI)
Change from baseline in toe-brachial index (TBI) of the study limb at 12 months. TBI is calculated as the ratio of toe systolic blood pressure to brachial systolic blood pressure (unitless ratio). Higher values indicate better distal perfusion.
Measured: Baseline and 12 months
Change in Transcutaneous Oxygen Pressure (TcPO2)
Change from baseline in transcutaneous oxygen pressure (TcPO2) of the study limb at 12 months, measured in mmHg. Higher values indicate better tissue oxygenation.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start2 Jun 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb-Threatening IschemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Chi Mei Medical Hospital, Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Donna Shu-Han Lin, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Donna SH Lin, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536373
- Sponsor's protocol ID
- 20250310R
- Acronym
- CIRCLE-Asia
- Status last verified
- Jul 2026
- First submitted
- 5 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine in Chronic Limb-Threatening Ischemia for Reduction of Complications and Limb Events in Asia
- ClinicalTrials.gov ID
- NCT07536373
- Acronym / sponsor ID
- CIRCLE-Asia / 20250310R
- Conditions
- Chronic Limb-Threatening Ischemia
- Keywords
- CIRCLE-Asia, Chronic limb-threatening ischemia, Peripheral artery disease, Colchicine, Amputation-free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Chi Mei Medical Hospital, Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, a condition in which narrowed or blocked arteries reduce blood flow to the legs. People with CLTI may have severe leg pain at rest, non-healing wounds, or gangrene, and face a high risk of leg amputation and death. Even after successful procedures to restore blood flow to the leg (called revascularization), many patients still experience serious complications. Inflammation in the blood vessels is believed to play an important role in these poor outcomes.
Colchicine is an anti-inflammatory medication that has been used safely for decades to treat gout and other inflammatory conditions. Recent large clinical trials have shown that a low dose of colchicine (0.5 mg per day) can reduce heart attacks and strokes in patients with coronary artery disease. However, it has not been studied in patients with CLTI.
The CIRCLE-Asia trial (Colchicine in Chronic Limb-Threatening Ischemia for Reduction of Complications and Limb Events in Asia) is a pilot study designed to evaluate whether colchicine can improve outcomes in patients with CLTI who have recently undergone a successful procedure to restore blood flow to their leg. Treatment begins within 7 days of the procedure.
This is a randomized, double-blind, placebo-controlled, multicenter trial conducted at five hospitals in Taiwan. A total of 200 adult patients with CLTI who have undergone successful revascularization will be randomly assigned in a 1:1 ratio to receive either colchicine 0.5 mg once daily or a matching placebo pill, in addition to their usual medications, for 12 months. Neither the patients nor the study doctors will know which treatment each patient receives.
The main outcome of interest is amputation-free survival, defined as the time until major amputation of the affected leg (above the ankle) or death from any cause, over 12 months of follow-up. The study will also assess other important outcomes including major limb complications, heart attacks, strokes, wound healing, changes in blood flow measurements, inflammatory blood markers, quality of life, and medication safety.
This pilot trial will provide the first randomized evidence on the potential benefits and safety of colchicine in CLTI patients and will help inform the design of a larger definitive trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine 0.5 MG Oral Tablet Once DailyColchicine 0.5 mg per tab, taken 1 tab daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets matching in appearance with study drug, taken 1 tab per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years.
- Documented chronic limb-threatening ischemia, meeting the following:
- Recent successful revascularization:
- Informed Consent:
Key exclusion criteria (16 listed)
- Age <18 years
- Asymptomatic or mild disease: Patients who underwent revascularization for disease graded Rutherford classes 0-3
- Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening
- Failure to establish at least one tibial artery outflow after revascularization
- Recent acute limb ischemia events within 2 weeks of screening
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 |
|---|---|---|
| Colchicine 0.5 MG Oral Tablet Once DailyColchicine 0.5 mg oral tablet (Colchicine Tablets 0.5mg, Synmosa), taken once daily in addition to standard of care, for 12 months. Treatment is initiated within 7 days of successful lower-extremity revascularization. For patients experiencing intolerance such as diarrhea or gastrointestinal discomfort, the dose may be reduced to 0.25 mg daily (half tablet). If the medication is considered harmful, treatment is interrupted and resumed when safe. | Drug | Colchicine |
| PlaceboMatching placebo tablet, identical in appearance to the colchicine 0.5 mg tablet (supplied by Synmosa Biopharma Corporation), taken orally once daily in addition to standard of care, for 12 months. Treatment is initiated within 7 days of successful lower-extremity revascularization. The same dose adjustment and discontinuation rules apply as for the active treatment arm. | Drug | Placebo |
Primary outcome
Amputation-free survival
Time frame: 12 months
Defined as the time to major (above the ankle) amputation of the study limb or death from any cause
19 secondary outcomes
Number of Participants with Major (Above the Ankle) Non-Traumatic Amputation of the Study Limb
Time frame: 12 months
Major adverse limb event (MALE, including non-traumatic above-ankle amputation and major lower limb artery reintervention) and its components
Time frame: 12 months
Major adverse cardiovascular event (MACE, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) and its components
Time frame: 12 months
Wound healing rates at 3, 6, 9 and 12 months for Rutherford 5 patients (or time to wound healing)
Time frame: 12 months
Number of Participants with Acute Limb Ischemia
Time frame: 12 months
Number of Deaths from Any Cause
Time frame: 12 months
Number of Deaths from Cardiovascular Causes
Time frame: 12 months
Number of Deaths from Limb-Related Causes
Time frame: 12 months
Number of Participants with Adverse Gastrointestinal Events
Time frame: 12 months
Number of Participants with Adverse Hematologic Events
Time frame: 12 months
Number of Participants with Serious Infections
Time frame: 12 months
Number of Participants with Diarrhea
Time frame: 12 months
Number of Participants with Drug Discontinuation Due to Any Adverse Event
Time frame: 12 months
Change in Health-Related Quality of Life as Measured by the EQ-5D-5L Index Score
Time frame: Baseline and 12 months
Change in Disease-Specific Quality of Life as Measured by the VASCUQOL-6 Score
Time frame: Baseline and 12 months
Change in Walking Ability as Measured by the Walking Impairment Questionnaire (WIQ) Score
Time frame: Baseline and 12 months
Change in Ankle-Brachial Index (ABI)
Time frame: Baseline and 12 months
Change in Toe-Brachial Index (TBI)
Time frame: Baseline and 12 months
Change in Transcutaneous Oxygen Pressure (TcPO2)
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- 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.
Donna SH Lin, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 MG Oral Tablet Once Daily in people with Chronic Limb-Threatening Ischemia, run by Shin Kong Wu Ho-Su Memorial Hospital at 5 sites 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 14 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna SH Lin, MD (+886-2-2833-2211, donna.lin24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation-free survival (time frame: 12 months). 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 14 Jul 2026.