Cryoneurolysis for Painful Diabetic Neuropathy of the Foot

Conditions

• Painful Diabetic Peripheral Neuropathy (PDPN)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cryoneurolysis — DEVICE
  Peripheral nerve cryoneurolysis of the foot
• sham cryoneurolysis — DEVICE
  a sham probe will be placed percutaneously proximal to target nerves. No cryoneurolysis will be given.

Study Details

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.

Key Dates

Start date

Aug 25, 2025

Status verified

Aug 2025

Primary completion

Dec 31, 2025

Completion

Jun 30, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Pain Intensity [ Time Frame: 1 month ]

Central Contacts

• Rodney A Gabriel, MD, MAS
  858-663-7747
  [email protected]
• Kyle Norton, MD
  702-209-9532
  [email protected]

Locations (1)

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