Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.

ClinicalTrials.gov 8 recruiting now early-phase tilt small index

Critical Limb Ischemia: early-phase trial registry

8 of 19 indexed Critical Limb Ischemia trials are currently recruiting, with more weight in Phase 1-2.

Corpus placement: #902 of 28,707 conditions by registered trial count.

19 US clinical trials · 8 currently recruiting · #902 of 28,707 conditions by registered trial count

Critical Limb Ischemia: 19 US clinical trials tracked, 8 recruiting.

Critical Limb Ischemia is the subject of 19 registered US clinical trials on ClinicalTrials.gov, 8 of them currently open to new participants. 3 are in Phase 3-4 (later-stage) and 6 in Phase 1-2 (earlier-stage). The most active sponsor is LimFlow, running 2 of these trials.

Enrollment posture brief

Registry condition critical-limb-ischemia

OPEN 8 | RECR 42% | LATE 3 | EARLY 6 | RANK #902 | SPON 2

Nearest open-share peer: Brain Concussion (42% recruiting · 19 trials)

Amyotrophic Lateral Sclerosi52.6%Anesthesia, Local42.1%Critical Limb Ischemia (this)42%Alcohol Consumption36.8%Attention Deficit Hyperactiv26.3%
Open-enrollment share among volume-matched conditions near Critical Limb Ischemia

Critical Limb Ischemia lists 8 open slots (42% of 19 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →

Key findings

What ClinicalTrials.gov does not surface for Critical Limb Ischemia on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.

  1. Critical Limb Ischemia is recruiting below its size-band peers.

    8 of 19 indexed trials (42.1%) are open to enrollment, against a 46.5% average across 27,806 conditions with fewer than 20 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.

  2. Sponsorship of Critical Limb Ischemia trials is spread across many organizations.

    LimFlow accounts for 2 of 19 trials (10.5%). 17 distinct sponsors appear on at least one study for this condition label.

  3. Most Critical Limb Ischemia trials plan to enrol fewer than 100 people.

    Median target enrolment is 41 among the 19 trials that report a genuine target (sentinel values excluded). 14 of those (73.7%) plan for fewer than 100 participants.

  4. Critical Limb Ischemia research is mostly interventional.

    16 interventional and 3 observational studies make up this index (84.2% interventional). Study type is sponsor-reported on ClinicalTrials.gov.

Phase 15Phase 21Phase 33

Open and recent trials

19 total, page 1 of 1

RECRUITING NA 292 participants

MOTIV BTK Randomized Controlled Trial

REVA Medical

NCT05406622

RECRUITING Phase 3 250 participants

Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee

Mercator MedSystems

NCT04433572

RECRUITING NA 100 participants

PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

LimFlow

NCT05313165

RECRUITING NA 60 participants

Serrantor OCT Study

Cagent Vascular

NCT06434194

RECRUITING Phase 3 50 participants

Trial to Assess Chelation Therapy in Critical Limb Ischemia

Mt. Sinai Medical Center, Miami

NCT03982693

RECRUITING 50 participants

CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

Yale University

NCT05145478

RECRUITING Early Phase 1 30 participants

Nutrition in Patient With Critical Limb Ischemia

Boston Medical Center

NCT03529019

RECRUITING 25 participants

Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention

University Hospitals Cleveland Medical Center

NCT06544135

COMPLETED NA 442 participants

Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

C. R. Bard

NCT01870401

COMPLETED NA 130 participants

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

COMPLETED Phase 1 53 participants

Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study

University of Southern California

NCT02091921

COMPLETED Phase 3 41 participants

An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)

Vericel Corporation

NCT01483898

COMPLETED 40 participants

Imaging-Guided Vessel Sizing in the Tibial Arteries

University Hospitals Cleveland Medical Center

NCT04748965

COMPLETED NA 32 participants

PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

LimFlow

NCT03124875

COMPLETED Phase 1 20 participants

ALD-301 for Critical Limb Ischemia, Randomized Trial

Aldagen

NCT00392509

COMPLETED Phase 1 12 participants

Safety Study of Gene Therapy in Treating Critical Leg Ischemia

Helixmith Co.

NCT00696124

COMPLETED Phase 2 7 participants

Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure

Ochsner Health System

NCT00651885

COMPLETED Phase 1 6 participants

Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)

Michael Murphy

NCT02863926

COMPLETED NA 5 participants

BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI

Zimmer Biomet

NCT02601430

Phase Distribution

PhaseTrial count
Phase 1 5
Phase 2 1
Phase 3 3

Named interventions

Most-linked intervention names on Critical Limb Ischemia records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.

Placebo Other
2 trials
LimFlow System Device
1 trials
BOLD-MRI Other
1 trials
Bare Temporary Spur Stent System Device
1 trials
ALDH-br bone marrow cells vs. mononuclear bone marrow cells Procedure
1 trials
Uncoated PTA Catheter Device
1 trials
Lutonix DCB Device
1 trials
treprostinil dienthanolmine sustained release Drug
1 trials

US sites by state

Facility locations filed on Critical Limb Ischemia trials. A trial with sites in several states counts in each.

Florida 5 trials
Connecticut 5 trials
California 5 trials
New York 4 trials
Illinois 4 trials
Ohio 3 trials
New Mexico 3 trials
Massachusetts 3 trials

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

What to do with this Critical Limb Ischemia page

19 registered trials, 8 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.

  • 8 Critical Limb Ischemia trials are currently recruiting, check eligibility criteria before contacting a site. Browse recruiting trials
  • LimFlow sponsors the most Critical Limb Ischemia trials on record, review their full trial history before evaluating a specific study. See LimFlow's trials
  • Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This Critical Limb Ischemia condition card totals 19 registered trials; most-linked intervention Placebo; top US site state Florida. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.