RECRUITING

Cryoneurolysis for Painful Diabetic Neuropathy of the Foot

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ultrasound-guided Percutaneous Cryoneurolysis for Management of Chronic Painful Diabetic Neuropathy: A Randomized Sham-controlled Pilot Study

Quick Facts

Study Start:2025-08-25
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06646731

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Research participants with diabetes mellitus and painful diabetic neuropathy of the foot (unilateral or bilateral)
  2. * HgbA1c \<10 (to avoid any increased risk of site infection)
  3. * Adult patients of at least 18 years of age
  4. * 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.
  1. * Diabetic neuropathy not in the distribution of the superficial peroneal nerve, sural nerve, deep peroneal, and/or distal saphenous nerve.
  2. * Comorbidities that are contraindication to cryoneurolysis (e.g., Reynaud syndrome, cryoglobulinemia, cold urticaria)
  3. * Allergy to local anesthetic
  4. * Pregnancy
  5. * Incarceration
  6. * Inability to communicate to investigators due to lack of capacity
  7. * Local infection in the foot/ankle where cryoneurolysis will be performed

Contacts and Locations

Study Contact

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 Locations (Sites)

University of California, San Diego
La Jolla, California, 92129
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-25
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-08-25
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Painful Diabetic Peripheral Neuropathy (PDPN)