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Procedure

Cryoneurolysis for Diabetic Neuropathy

N/A

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Research participants with diabetes mellitus and painful diabetic neuropathy of the foot (unilateral or bilateral)

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.

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial is studying the use of a technique called ultrasound-guided percutaneous cryoneurolysis to treat diabetic neuropathy of the foot. Cryoneurolysis involves freezing a nerve to

Who is the study for?

This trial is for adults with diabetes who have moderate to severe foot pain from diabetic neuropathy, and a HgbA1c level below 10. They must be able to communicate with researchers and not have any local infection at the treatment site, allergies to local anesthetics, conditions that don't mix well with cryoneurolysis like Reynaud syndrome, or be pregnant.

What is being tested?

The study tests if freezing nerves through ultrasound-guided cryoneurolysis can reduce foot pain in diabetic neuropathy patients compared to a sham procedure. Participants are randomly assigned to either the real treatment or a fake one without knowing which they receive.

What are the potential side effects?

Cryoneurolysis involves minimal discomfort and has no systemic side effects; it's non-addictive. There may be risks typical of procedures involving skin penetration such as infection or localized reactions but these are not specified.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have diabetes and experience painful nerve pain in my foot or feet.

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I have daily foot pain from diabetes rated 3 or higher for the last 2 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My diabetic nerve pain is not in my lower leg or foot.

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I do not have conditions like Reynaud's, cryoglobulinemia, or cold urticaria.

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I have an infection in my foot/ankle where a cold therapy treatment is planned.

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I cannot communicate my health needs due to mental or physical reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Intensity

Secondary study objectives

Opioid consumption - 1 month

Opioid consumption - 1 week

Opioid consumption - 3 months

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CryoneurolysisActive Control1 Intervention

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.

Group II: ShamPlacebo Group1 Intervention

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.

0 / 6Eligibility criteria met