Cryoneurolysis for Diabetic Neuropathy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The study is a single-center, randomized, participant- and observer-masked, human-subjects, post-market clinical pilot study to investigate the use of ultrasound-guided percutaneous cryoneurolysis to treat diabetic neuropathy of the foot. A prolonged nerve block may be provided by freezing the nerve using a technique called "cryoneurolysis". With cryoneurolysis and ultrasound machines, a small needle-like "probe" may be placed through anesthetized skin and guided to the target nerve to allow freezing. The procedure takes about 6 minutes for each nerve, involves little discomfort, has no systemic side effects, and cannot be misused or become addictive. Participants will be randomly allocated to one of two possible treatments groups: cryoneurolysis (experimental) or sham (control). The primary outcome measure is the change in pain on the neuropathic pain scale from baseline 1 month following the procedure.

Research Team

Eligibility Criteria

This trial is for adults with diabetes who have moderate to severe foot pain from diabetic neuropathy, and a HgbA1c level below 10. They must be able to communicate with researchers and not have any local infection at the treatment site, allergies to local anesthetics, conditions that don't mix well with cryoneurolysis like Reynaud syndrome, or be pregnant.

Inclusion Criteria

HgbA1c <10 (to avoid any increased risk of site infection)

I am 18 years old or older.

I have diabetes and experience painful nerve pain in my foot or feet.

Exclusion Criteria

Incarceration

Allergy to local anesthetic

My diabetic nerve pain is not in my lower leg or foot.

Treatment Details

Interventions

• Cryoneurolysis (Procedure)
• Sham Cryoneurolysis (Procedure)

Trial Overview The study tests if freezing nerves through ultrasound-guided cryoneurolysis can reduce foot pain in diabetic neuropathy patients compared to a sham procedure. Participants are randomly assigned to either the real treatment or a fake one without knowing which they receive.

Participant Groups

Group I: Cryoneurolysis Active Control 1 Intervention

For participants randomized to active treatment, the probe placed in the research participant will be triggered and the nitrous oxide passed through the probe and then back into the machine, and finally vented out from the console. This will result in a freeze-thaw cycle. This may be repeated, as necessary, to ensure the entire cross-section of each nerve is fully treated.

Group II: Sham Placebo Group 1 Intervention

Patients in this arm will also receive a diagnostic block with local anesthetic. If pain relief is satisfactory, the patients in this arm will undergo the procedure but the cryo probe will simply not be activated.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University