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Critical Limb Ischemia clinical trials
Every US clinical trial registered for Critical Limb Ischemia — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.
19 US clinical trials · 8 currently recruiting
The research picture
Critical Limb Ischemia has 19 registered US clinical trials, 8 of them open to new participants right now — about 42% of the total.
- 8
- recruiting participants now
- 42%
- of trials open to enrollment
- 3
- in Phase 3–4 (later-stage)
- 2
- top sponsor: LimFlow
Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.
Active & Recent Trials
MOTIV BTK Randomized Controlled Trial
REVA Medical
NCT05406622
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
Mercator MedSystems
NCT04433572
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
LimFlow
NCT05313165
Serrantor OCT Study
Cagent Vascular
NCT06434194
Trial to Assess Chelation Therapy in Critical Limb Ischemia
Mt. Sinai Medical Center, Miami
NCT03982693
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Yale University
NCT05145478
Nutrition in Patient With Critical Limb Ischemia
Boston Medical Center
NCT03529019
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
University Hospitals Cleveland Medical Center
NCT06544135
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
C. R. Bard
NCT01870401
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
ReFlow Medical
NCT05358353
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
University of Southern California
NCT02091921
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
Vericel Corporation
NCT01483898
Imaging-Guided Vessel Sizing in the Tibial Arteries
University Hospitals Cleveland Medical Center
NCT04748965
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
LimFlow
NCT03124875
ALD-301 for Critical Limb Ischemia, Randomized Trial
Aldagen
NCT00392509
Safety Study of Gene Therapy in Treating Critical Leg Ischemia
Helixmith Co.
NCT00696124
Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
Ochsner Health System
NCT00651885
Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
Michael Murphy
NCT02863926
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
Zimmer Biomet
NCT02601430
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 5 |
| Phase 2 | 1 |
| Phase 3 | 3 |
Top Sponsors
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Reading the Critical Limb Ischemia Trial Landscape
ClinicalTrials.gov lists 19 US studies indexed under Critical Limb Ischemia, and 8 of those are currently open to recruitment — roughly 42% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.
The phase distribution for Critical Limb Ischemia shows 3 late-stage studies (Phase 3 and Phase 4 combined) alongside 6 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.
Top sponsor activity for Critical Limb Ischemia is led by LimFlow with 2 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 19 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.
Frequently Asked Questions
How many clinical trials are there for Critical Limb Ischemia?
PlainTrial tracks 19 US clinical trials for Critical Limb Ischemia, of which 8 are currently recruiting participants. Data sourced from ClinicalTrials.gov.
How do I find a recruiting trial for Critical Limb Ischemia?
Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.
Is this data current?
Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.
Related
Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.
Read our methodology — how this data is sourced, computed, and verified.
Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.