Cryoneurolysis for Painful Diabetic Neuropathy of the Foot
Active, not recruitingNot applicableNCT06646731
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Ultrasound-guided Percutaneous Cryoneurolysis for Management of Chronic Painful Diabetic Neuropathy: A Randomized Sham-controlled Pilot Study
- Conditions
- Painful Diabetic Peripheral Neuropathy (PDPN)
- Interventions
- Device: cryoneurolysis
- Device: sham cryoneurolysis
- Sponsor
- University of California, San Diego
- Start date
- 2025-08-25
- Primary completion
- 2026-08
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06646731