Actively Recruiting
Cryoneurolysis for Painful Diabetic Neuropathy of the Foot
Led by University of California, San Diego · Updated on 2025-09-05
30
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cryoneurolysis for Painful Diabetic Neuropathy of the Foot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with diabetes mellitus and painful diabetic neuropathy of the foot (one or both feet)
- Hemoglobin A1c (HgbA1c) less than 10 to reduce infection risk
- Experiencing moderate or greater neuropathic foot pain (3 or higher on a 0-10 scale) at least daily for the last 2 months
You will not qualify if you...
- Neuropathy not involving the superficial peroneal, sural, distal saphenous, or deep peroneal nerves
- Conditions contraindicating cryoneurolysis, such as Reynaud syndrome, cryoglobulinemia, or cold urticaria
- Allergy to local anesthetics
- Pregnancy
- Being incarcerated
- Unable to communicate with investigators due to lack of capacity
- Local infection in the foot or ankle where treatment would be applied
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92129
Actively Recruiting
Research Team
R
Rodney A Gabriel, MD, MAS
CONTACT
K
Kyle Norton, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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