Cryoneurolysis to reduce painful diabetic neuropathy of the foot
Ultrasound-guided Percutaneous Cryoneurolysis for Management of Chronic Painful Diabetic Neuropathy: A Randomized Sham-controlled Pilot Study
This pilot will try ultrasound-guided cryoneurolysis to reduce foot pain in adults with diabetic peripheral neuropathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06646731 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, participant- and observer-masked pilot enrolls 30 adults with painful diabetic peripheral neuropathy of the foot and randomizes them to ultrasound-guided percutaneous cryoneurolysis or a sham procedure. Under local anesthesia a small probe is guided by ultrasound to freeze the target superficial peroneal (or other target) nerve for about six minutes per nerve, producing a temporary nerve block that typically resolves after 2–3 months. The primary outcome is change in neuropathic pain scale score from baseline to one month post-procedure, with additional follow-up to monitor safety and duration of effect. Patients with contraindications to cold-based interventions or with neuropathy outside the targeted nerve distributions are excluded.
Who should consider this trial
Good fit: Adults (≥18) with diabetes, daily foot neuropathic pain rated ≥3 on the NRS for at least two months, HgbA1c <10, and neuropathy in the distribution of the superficial peroneal, sural, deep peroneal, or distal saphenous nerve.
Not a fit: Patients whose neuropathy is outside the targeted nerves or who have contraindications to cryotherapy (for example Raynaud syndrome, cryoglobulinemia, cold urticaria, local foot infection, pregnancy) are unlikely to benefit.
Why it matters
Potential benefit: If effective, cryoneurolysis could provide months-long localized pain relief and reduce reliance on systemic pain medications.
How similar studies have performed: Cryoneurolysis has provided pain relief in other peripheral nerve and postoperative settings, but high-quality controlled data specifically for diabetic foot neuropathy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Diabetic neuropathy not in the distribution of the superficial peroneal nerve, sural nerve, deep peroneal, and/or distal saphenous nerve. * Comorbidities that are contraindication to cryoneurolysis (e.g., Reynaud syndrome, cryoglobulinemia, cold urticaria) * Allergy to local anesthetic * Pregnancy * Incarceration * Inability to communicate to investigators due to lack of capacity * Local infection in the foot/ankle where cryoneurolysis will be performed
Where this trial is running
La Jolla, California
- University of California, San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Study coordinator: Rodney A Gabriel, MD, MAS
- Email: ragabriel@health.ucsd.edu
- Phone: 858-663-7747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.