Cryoneurolysis for Painful Diabetic Neuropathy of the Foot

NCT06646731 | Recruiting FDA Device

• 1 other identifier: 811212
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Painful Diabetic Peripheral Neuropathy (PDPN)

Keywords

Cryoneurolysis; Diabetic Peripheral Neuropathy of the Foot; Chronic Pain; Ultrasound-Guided Percutaneous Cryoneurolysis

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Change in pain intensity compared to baseline due to diabetic neuropathy of the foot as measured by the score of the Neuropathic Pain Scale. The primary outcome will be at 1 month following the study procedure. The primary statistic will be comparing the median change in the neuropathic pain scale score between both cohorts.

  1 month

Secondary Outcomes (10)

• Perception of Well-Being

  1 month

• Physical and Emotional Functioning

  1 month

• Pain intensity - 1 month

  1 month

• Pain Intensity - 1 week

  1 week

• Pain Intensity - 3 months

  3 months

Study Arms (2)

Cryoneurolysis

ACTIVE COMPARATOR

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.

Device: cryoneurolysis

Sham

SHAM COMPARATOR

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.

Device: sham cryoneurolysis

Interventions

cryoneurolysis DEVICE

Peripheral nerve cryoneurolysis of the foot

Cryoneurolysis

sham cryoneurolysis DEVICE

a sham probe will be placed percutaneously proximal to target nerves. No cryoneurolysis will be given.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92129, United States

RECRUITING

Related Publications (4)

• Yoon JH, Grechushkin V, Chaudhry A, Bhattacharji P, Durkin B, Moore W. Cryoneurolysis in Patients with Refractory Chronic Peripheral Neuropathic Pain. J Vasc Interv Radiol. 2016 Feb;27(2):239-43. doi: 10.1016/j.jvir.2015.11.027. Epub 2015 Dec 17.

  PMID: 26710969 BACKGROUND

• Jay GW, Barkin RL. Neuropathic pain: etiology, pathophysiology, mechanisms, and evaluations. Dis Mon. 2014 Jan;60(1):6-47. doi: 10.1016/j.disamonth.2013.12.001. No abstract available.

  PMID: 24507705 BACKGROUND

• Gabriel RA, Seng EC, Curran BP, Winston P, Trescot AM, Filipovski I. A Narrative Review of Ultrasound-Guided and Landmark-based Percutaneous Cryoneurolysis for the Management of Acute and Chronic Pain. Curr Pain Headache Rep. 2024 Nov;28(11):1097-1104. doi: 10.1007/s11916-024-01281-z. Epub 2024 Jul 4.

  PMID: 38963513 BACKGROUND

• Filipovski I, Gabriel RA, Kestenholz R. Ultrasound-Guided Cryoneurolysis for the Treatment of Painful Diabetic Neuropathy of the Foot: A Case Series. Cureus. 2024 Mar 16;16(3):e56267. doi: 10.7759/cureus.56267. eCollection 2024 Mar.

  PMID: 38495961 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rodney A Gabriel, MD, MAS

CONTACT

858-663-7747; ragabriel@health.ucsd.edu

Kyle Norton, MD

CONTACT

702-209-9532; kfnorton@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study is a single-center, randomized, participant- and observer-masked, human-subjects, post-market clinical pilot study

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: August 25, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (1)