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Freezing nerves could offer new hope for diabetic foot pain

NCT ID NCT06646731

Symptom relief Sponsor: University of California, San Diego Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests a procedure called cryoneurolysis, which uses a small probe to freeze nerves in the foot and block pain signals. It is for adults with painful diabetic neuropathy who have at least moderate pain daily. Thirty participants will be randomly assigned to receive either the real freezing treatment or a sham (fake) procedure, and researchers will compare pain levels one month later.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Chronic Pain diabetic neuropathy diabetic polyneuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Painful diabetic peripheral neuropathy (PDPN)

Contacts and locations

Locations

  • University of California, San Diego

    La Jolla, California, 92129, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.