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NCT06646731 · ClinicalTrials.gov registry record · NA
Cryoneurolysis for Painful Diabetic Neuropathy of the Foot
A NA study of Painful Diabetic Peripheral Neuropathy (PDPN), sponsored by University of California, San Diego.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06646731: Recruiting NA study of Painful Diabetic Peripheral Neuropathy (PDPN), sponsored by University of California, San Diego.
NCT06646731 is a NA study of Painful Diabetic Peripheral Neuropathy (PDPN) that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06646731, a NA study of Painful Diabetic Peripheral Neuropathy (PDPN), is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE cryoneurolysis
- DEVICE sham cryoneurolysis
Study Locations (1)
California
- University of California, San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-08-25 |
| Est. Completion | 2026-06 |
| Phase | NA |
What NCT06646731 shows while recruiting
NCT06646731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Painful Diabetic Peripheral Neuropathy (PDPN) appearing as the primary indexed condition, and to 2 interventions - of which cryoneurolysis is the first listed.
NCT06646731 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06646731 about?
NCT06646731 is a clinical study titled "Cryoneurolysis for Painful Diabetic Neuropathy of the Foot". 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...
What is the current status of trial NCT06646731?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2025-08-25. Estimated completion is 2026-06.
What conditions does trial NCT06646731 study?
This clinical trial studies the following conditions: Painful Diabetic Peripheral Neuropathy (PDPN).
What interventions are being tested in trial NCT06646731?
The interventions under investigation include: cryoneurolysis (DEVICE), sham cryoneurolysis (DEVICE).
Who is sponsoring clinical trial NCT06646731?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06646731 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06646731's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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