Ultrasound-guided Percutaneous Cryoneurolysis for Management of Chronic Painful Diabetic Neuropathy: A Randomized Sham-controlled Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Research participants with diabetes mellitus and painful diabetic neuropathy of the foot (unilateral or bilateral)

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

• Adult patients of at least 18 years of age

• Experiencing at least moderate diabetic neuropathic pain in the foot - defined as 3 or higher on the numeric rating scale (NRS; 0-10, 0=no pain; 10=worse imaginable pain) - at least daily for the previous 2 months.

Locations
United States
California
University of California, San Diego
RECRUITING
La Jolla
Contact Information
Primary
Rodney A Gabriel, MD, MAS
ragabriel@health.ucsd.edu
858-663-7747
Backup
Kyle Norton, MD
kfnorton@health.ucsd.edu
702-209-9532
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2026-06
Participants
Target number of participants: 30
Treatments
Active_comparator: Cryoneurolysis
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.
Sham_comparator: Sham
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov