Cryoneurolysis for Painful Diabetic Neuropathy of the Foot
Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Oct 15, 2024
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called cryoneurolysis for people suffering from painful diabetic neuropathy in their feet, a common condition for those with diabetes that causes discomfort and pain. The trial will involve a procedure where a small, needle-like tool is used to freeze specific nerves in the foot, which may help to relieve pain. Participants will be randomly assigned to either receive the actual treatment or a sham treatment (which does not provide any real effect) to compare the results.
To be eligible for this trial, participants should be adults aged 18 or older, have diabetes, and experience moderate to severe foot pain on most days. They must also have specific types of nerve pain and not have certain medical conditions or allergies that could interfere with the procedure. The trial is not yet recruiting participants, but those who join can expect a quick, minimally uncomfortable procedure that takes about six minutes per nerve. The main goal is to see how much pain relief participants experience one month after the treatment.
Gender
ALL
Eligibility criteria
- 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
About University Of California, San Diego
The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
La Jolla, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported