CLTI Defined as Rutherford Category 4 or 5Phase 3DAPTCLTINCT07512960
Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization
A Phase 3 study testing Clopidogrel 75 mg/day in people with CLTI Defined as Rutherford Category 4 or 5, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to relieve ischemic pain, prevent limb loss and preserve patient autonomy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- CLTI Defined as Rutherford Category 4 or 5
- What is being tested?
- Clopidogrel 75 mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 614 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2026to 30 Nov 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Hospitalized patients with CLTI defined as Rutherford category 4 (ischemic rest pain) or 5 (minor tissue loss, non-healing ulcer, focal gangrene) evolving for > 2 weeks + one or more abnormal hemodynamic parameters: ankle-brachial index (ABI) <0.4 (using higher of the dorsalis pedis and posterior tibial arteries), absolute highest ankle pressure <50 mm Hg, absolute toe pressure <30 mm Hg.
- Successful endovascular revascularization involving below-the-knee arteries (angioplasty/stenting) alone or combining above- and below-the-knee revascularization within the last 7 days prior to randomization
- Affiliation to a French Health Insurance system
- Patient able to understand and sign a written informed consent form.
- In women of childbearing potential: negative serum pregnancy test and use of adequate contraception.
- (According to CTFG guidelines, a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.)
Who cannot join
- PAD Rutherford category 0, 1, 2, 3 or 6 (Rutherford 6 defined as severe
- ischemic ulcers or foot gangrene exceeding the digits)
- Acute limb ischemia within one month prior to the qualifying revascularization
- Platelet count < 100x109/L
- Need for dual antiplatelet therapy for other reason than PAD
- Need for concomitant treatment with anticoagulant (VKA or DOAC [except low dose rivaroxaban 2.5 mg x 2])
Show all 23Show fewer
- Known allergy or hypersensitivity to aspirin/clopidogrel
- Exclusion criteria related to bleeding risks or systemic conditions:
- Medical history or active clinically significant bleeding, lesions, or conditions within the last 6 months prior to inclusion, considered to be a significant risk for major bleeding (this may include current medically confirmed gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, current or recent brain or spinal injury, known esophageal varices, or major intraspinal or intracerebral vascular abnormalities;
- Severe hepatic impairment or any known hepatic disease associated with coagulopathy or bleeding risk;
- Any condition requiring dialysis or renal replacement therapy or a renal impairment at screening assessed with an estimated glomerular filtration rate <15 mL/min/1.73 m2 (if a patient's eGFR is <30 mL/min/1.73 m2 prior to the procedure, it must remain >15 mL/min/1.73 m2 72 hours after the procedure to enroll and randomize the patient);
- Confirmed acute coronary syndrome (ACS) within 30 days prior to inclusion; Major trauma or accidents within 30 days prior to inclusion;
- Any medically documented history of intracranial hemorrhage, stroke, or transient ischemic attack (TIA);
- Known active malignancy (as determined through review of medical history), excluding local skin cancer (basal or squamous cell carcinoma);
- Poorly controlled diabetes (at the discretion of the investigator);
- Severe uncontrolled hypertension (at the discretion of investigator);
- Other exclusion criteria :
- Previous (within 30 days) or concomitant participation in another clinical interventional study (drug or device)
- Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee or student of the investigational site)
- Expected impossible follow-up or poor compliance
- Patient deprived of liberty
- Patient under tutorship, curatorship, or legal protection
- Documented pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospital Saint Joseph
Paris, Île-de-France Region, 75014
Joseph Emmerich Professor, MD, +33 1 44 12 37 64, jemmerich@ghpsj.fr
About this study
Official title: Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization: a Randomized, Double-blind Trial PALADIN [PeripherAL Arterial DIsease Network] -DAPTCLTI
Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to relieve ischemic pain, prevent limb loss and preserve patient autonomy. Revascularization procedures often involve below-the-knee arterial disease in CLTI population. Dual antiplatelet therapy (DAPT, with aspirin, and clopidogrel) is recommended for at least 1-month after peripheral angioplasty. However, the exact duration of this DAPT remains controversial. Angioplasty of below-the-knee arteries is often followed by a longer period of DAPT, 3-months to one-year, due to a high risk of arterial thrombosis/stenosis.It will be the first trial on duration of DAPT in patients with below-the-knee angioplasty for CLTI, the end-stage of PAD
Read the detailed description
Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD). This condition is associated with increased risk of mortality and major amputation and has become a global health problem. Revascularization is the cornerstone of therapy to relieve ischemic pain, prevent limb loss and preserve patient autonomy. Revascularization procedures often involve below-the-knee arterial disease in CLTI population. Despite limb salvage procedure, recent reports still highlight the poor survival in this population. Mortality rate remains high, up to 25% of patients during the first year of follow-up after endovascular revascularization procedure. This poor overall survival isconstantly underlined in literature, with cardiovascular events as the main cause of death, followed by limb adverse events.
Dual antiplatelet therapy (DAPT, with aspirin, and clopidogrel) is recommended for at least 1-month after peripheral angioplasty. However, the exact duration of this DAPT remains controversial. Angioplasty of below-the-knee arteries is often followed by a longer period of DAPT, 3-months to one-year, due to a high risk of arterial thrombosis/stenosis. Current European or American guidelines are inconsistent concerning antithrombotic strategies after below-the knee revascularization. Most of the current antithrombotic strategy after PAD angioplasty is mainly extrapolated from coronary artery strategy. There is no randomized study after PAD revascularization in CLTI assessing the duration of DAPT. In the recent VOYAGER PAD study only 6.2% of the patients had a below-the-knee revascularization.
Antithrombotic management following below-the-knee revascularization procedure is thus challenging in everyday practice. Almost invariably, longer exposure to DAPT would lead to more bleeding, and the precise risk-to-benefit ratio can hardly be codified. We considered of paramount importance to adequately study the duration of DAPT in the most severe field of PAD. The design of PALADIN-DAPTCLTI, a randomized double-blind trial, will allow to assess the potential benefit of 12 months DAPT in patients with below-the-knee angioplasty and will carefully assess the safety of this strategy.
It will be the first trial on duration of DAPT in patients with below-the-knee angioplasty for CLTI, the end-stage of PAD.
Furthermore, despite limb salvage, patients with CLTI do not always experience sustained gain in their quality of life and repeat procedures likely adversely affect their health status. Along with other clinical endpoints and long-term cost effectiveness, patient-reported outcome in terms of quality of life in the post-procedural period will also be particularly relevant.
- Being tested
- Clopidogrel 75 mg/day, Placebo Clopidogrel
- Keywords
- Arterial angioplasty, Percutaneous transluminal angioplasty, Arterial thrombosis limb, Arterial thrombosis, Atherothrombosis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel 75 mg/dayDrug
After inclusion and randomization at one-month, the intervention group will receive clopidogrel 75 mg/day for 11 months and the control a placebo of clopidogrel/day for 11 months
Placebo ClopidogrelOther
After inclusion and randomization at one-month, the control group will receive a placebo of clopidogrel/day for 11 months
| Study group | Role | What they receive |
|---|---|---|
| CLOPIDOGREL | Experimental | 11-months of clopidogrel 75 mg/day Receives: Drug: Clopidogrel 75 mg/day |
| PLACEBO CLOPIDOGREL | Placebo comparator | 11-months of placebo of clopidogrel Receives: Other: Placebo Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation-free survival at 12 months
Amputation-free survival at 12 months, defined as time from randomization until major amputation (defined as above-the-ankle amputation) or death from any cause, whichever occurs first, for all subjects.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start12 Jun 2026
- Primary completion30 May 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CLTI Defined as Rutherford Category 4 or 5Studies 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
- Model description
- clopidogrel 75 mg/day (intervention group), placebo of clopidogrel (control group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Emmerich, Pr, Principal investigator, Hôpital Paris Saint Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512960
- Sponsor's protocol ID
- 729_PALADIN-DAPTCLTI
- Acronym
- DAPTCLTI
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abola MT, Bhatt DL, Duval S, Cacoub PP, Baumgartner I, Keo H, Creager MA, Brennan DM, Steg PG, Hirsch AT; REACH Investigators. Fate of individuals with ischemic amputations in the REACH Registry: three-year cardiovascular and limb-related outcomes. Atherosclerosis. 2012 Apr;221(2):527-35. doi: 10.1016/j.atherosclerosis.2012.01.002. Epub 2012 Jan 24.
PubMed 22321872Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
PubMed 28886620Allemang MT, Rajani RR, Nelson PR, Hingorani A, Kashyap VS. Prescribing patterns of antiplatelet agents are highly variable after lower extremity endovascular procedures. Ann Vasc Surg. 2013 Jan;27(1):62-7. doi: 10.1016/j.avsg.2012.05.001. Epub 2012 Sep 12.
PubMed 22981017Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.
PubMed 29540326
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization: a Randomized, Double-blind Trial PALADIN [PeripherAL Arterial DIsease Network] -DAPTCLTI
- ClinicalTrials.gov ID
- NCT07512960
- Acronym / sponsor ID
- DAPTCLTI / 729_PALADIN-DAPTCLTI
- Keywords
- Arterial angioplasty, Percutaneous transluminal angioplasty, Arterial thrombosis limb, Arterial thrombosis, Atherothrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 614 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 30 May 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 6 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 defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to relieve ischemic pain, prevent limb loss and preserve patient autonomy. Revascularization procedures often involve below-the-knee arterial disease in CLTI population. Dual antiplatelet therapy (DAPT, with aspirin, and clopidogrel) is recommended for at least 1-month after peripheral angioplasty. However, the exact duration of this DAPT remains controversial. Angioplasty of below-the-knee arteries is often followed by a longer period of DAPT, 3-months to one-year, due to a high risk of arterial thrombosis/stenosis.It will be the first trial on duration of DAPT in patients with below-the-knee angioplasty for CLTI, the end-stage of PAD
Detailed description
Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD). This condition is associated with increased risk of mortality and major amputation and has become a global health problem. Revascularization is the cornerstone of therapy to relieve ischemic pain, prevent limb loss and preserve patient autonomy. Revascularization procedures often involve below-the-knee arterial disease in CLTI population. Despite limb salvage procedure, recent reports still highlight the poor survival in this population. Mortality rate remains high, up to 25% of patients during the first year of follow-up after endovascular revascularization procedure. This poor overall survival isconstantly underlined in literature, with cardiovascular events as the main cause of death, followed by limb adverse events.
Dual antiplatelet therapy (DAPT, with aspirin, and clopidogrel) is recommended for at least 1-month after peripheral angioplasty. However, the exact duration of this DAPT remains controversial. Angioplasty of below-the-knee arteries is often followed by a longer period of DAPT, 3-months to one-year, due to a high risk of arterial thrombosis/stenosis. Current European or American guidelines are inconsistent concerning antithrombotic strategies after below-the knee revascularization. Most of the current antithrombotic strategy after PAD angioplasty is mainly extrapolated from coronary artery strategy. There is no randomized study after PAD revascularization in CLTI assessing the duration of DAPT. In the recent VOYAGER PAD study only 6.2% of the patients had a below-the-knee revascularization.
Antithrombotic management following below-the-knee revascularization procedure is thus challenging in everyday practice. Almost invariably, longer exposure to DAPT would lead to more bleeding, and the precise risk-to-benefit ratio can hardly be codified. We considered of paramount importance to adequately study the duration of DAPT in the most severe field of PAD. The design of PALADIN-DAPTCLTI, a randomized double-blind trial, will allow to assess the potential benefit of 12 months DAPT in patients with below-the-knee angioplasty and will carefully assess the safety of this strategy.
It will be the first trial on duration of DAPT in patients with below-the-knee angioplasty for CLTI, the end-stage of PAD.
Furthermore, despite limb salvage, patients with CLTI do not always experience sustained gain in their quality of life and repeat procedures likely adversely affect their health status. Along with other clinical endpoints and long-term cost effectiveness, patient-reported outcome in terms of quality of life in the post-procedural period will also be particularly relevant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- clopidogrel 75 mg/day (intervention group), placebo of clopidogrel (control group
| Arm | Type | Receives |
|---|---|---|
| CLOPIDOGREL | Experimental | Drug: Clopidogrel 75 mg/day11-months of clopidogrel 75 mg/day |
| PLACEBO CLOPIDOGREL | Placebo comparator | Other: Placebo Clopidogrel11-months of placebo of clopidogrel |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Hospitalized patients with CLTI defined as Rutherford category 4 (ischemic rest pain) or 5 (minor tissue loss, non-healing ulcer, focal gangrene) evolving for > 2 weeks + one or more abnormal hemodynamic parameters: ankle-brachial index (ABI) <0.4 (using higher of the dorsalis pedis and posterior tibial arteries), absolute highest ankle pressure <50 mm Hg, absolute toe pressure <30 mm Hg.
- Successful endovascular revascularization involving below-the-knee arteries (angioplasty/stenting) alone or combining above- and below-the-knee revascularization within the last 7 days prior to randomization
- Affiliation to a French Health Insurance system
- Patient able to understand and sign a written informed consent form.
Key exclusion criteria (23 listed)
- PAD Rutherford category 0, 1, 2, 3 or 6 (Rutherford 6 defined as severe
- ischemic ulcers or foot gangrene exceeding the digits)
- Acute limb ischemia within one month prior to the qualifying revascularization
- Platelet count < 100x109/L
- Need for dual antiplatelet therapy for other reason than PAD
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 |
|---|---|---|
| Clopidogrel 75 mg/dayAfter inclusion and randomization at one-month, the intervention group will receive clopidogrel 75 mg/day for 11 months and the control a placebo of clopidogrel/day for 11 months | Drug | CLOPIDOGREL |
| Placebo ClopidogrelAfter inclusion and randomization at one-month, the control group will receive a placebo of clopidogrel/day for 11 months | Other | PLACEBO CLOPIDOGREL |
Primary outcome
Amputation-free survival at 12 months
Time frame: 12 months
Amputation-free survival at 12 months, defined as time from randomization until major amputation (defined as above-the-ankle amputation) or death from any cause, whichever occurs first, for all subjects.
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 24 Jun 2026.
- Results publication: PubMed 22321872Abola MT, Bhatt DL, Duval S, Cacoub PP, Baumgartner I, Keo H, Creager MA, Brennan DM, Steg PG, Hirsch AT; REACH Investigators. Fate of individuals with ischemic amputations in the REACH Registry: three-year cardiovascular and limb-related outcomes. Atherosclerosis. 2012 Apr;221(2):527-35. doi: 10.1016/j.atherosclerosis.2012.01.002. Epub 2012 Jan 24.
- Results publication: PubMed 28886620Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
- Results publication: PubMed 22981017Allemang MT, Rajani RR, Nelson PR, Hingorani A, Kashyap VS. Prescribing patterns of antiplatelet agents are highly variable after lower extremity endovascular procedures. Ann Vasc Surg. 2013 Jan;27(1):62-7. doi: 10.1016/j.avsg.2012.05.001. Epub 2012 Sep 12.
- Results publication: PubMed 29540326Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.
- Individual participant dataSharing planned: No
Related trials for CLTI Defined as Rutherford Category 4 or 5
Active, not recruiting
Resoloy Initial Safety Evaluation
CLTI Defined as Rutherford Category 4 or 5, PAOD (Peripheral Arterial Obstructive Disease)
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.
Joseph Emmerich, Pr principal investigator
Hôpital Paris Saint Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel 75 mg/day in people with CLTI Defined as Rutherford Category 4 or 5, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 7 inclusion and 23 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 24 Jun 2026. 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 France. 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 Joseph Emmerich, Pr (+33 1 44 12 37 64, jemmerich@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation-free survival at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07512960, which also lists 4 linked publications.
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 24 Jun 2026.