Peripheral Neuropathy Trial, Recruiting NCT06287736 Sponsor: Ohio State University Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT06287736
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are over 18 years old
  • People who have been diagnosed with diabetic peripheral neuropathy (nerve pain related to diabetes) that has not responded to gabapentin or pregabalin, as well as at least one other type of pain medication
  • People whose pain from diabetic nerve damage has not been adequately controlled by medical treatment
  • People who have had pain for at least 12 months
  • People whose lower limb (leg or foot) pain rates 4 or higher on a standard pain scale
  • People who score 4 or higher on a questionnaire called the DN4, which is used to assess nerve-related pain
  • People in the surgical group who have passed a psychological assessment done before any procedure
  • People who are able to understand and agree to take part in the study by providing informed consent

Who may not be able to join:

  • People with serious medical conditions that, in the treating surgeon's judgment, make surgery unsafe
  • People who have significant spinal problems, such as severe narrowing of the spinal canal or pressure on the spinal cord, in the area where a device would need to be placed
  • People with a blood clotting disorder that cannot be corrected
  • People who are unable to stop taking blood-thinning medications
  • People whose HbA1c (a measure of long-term blood sugar levels) is higher than 10
  • People who currently have an active infection anywhere in the body
  • People who are pregnant

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Brian Dalm, MD, Ohio State University

Phone: 614-366-7822

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Ohio State University
Registry
ClinicalTrials.gov
Start date
17 April 2024
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Pain level; Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4); Change in PROMIS quality of life in relation to pain level

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov