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Which treatment works best for diabetic nerve pain?

NCT ID NCT07795593

Disease control Sponsor: University of Michigan 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial compares three approaches for treating painful diabetic neuropathy: oral medications, topical treatments, and cognitive behavioral therapy. Researchers will enroll 600 adults with diabetes and nerve pain, randomly assigning them to one of these options for four months. If the first treatment does not relieve pain, participants will either switch to a different modality or continue with the same one, to see which strategy works better. The study measures pain intensity, side effects, and how well each treatment is tolerated over eight months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive behavioral therapy (CBT) and oral medications such as duloxetine, venlafaxine, amitriptyline, and nortriptyline
What this could lead to
If successful, this trial could help doctors choose the best first treatment for painful diabetic neuropathy and guide what to do when that treatment fails, improving pain relief and reducing side effects.
What could go wrong
The trial is early and results may not apply to everyone. Some oral medications can cause side effects like drowsiness or nausea, and not all patients respond to the same treatment.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 600 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

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: * Diabetes * Painful Diabetic Neuropathy (confirmed at screening visit) * Willing to accept random treatment assignment to any of the proposed interventions Exclusion Criteria: * Pregnancy or plans to become pregnant during the study * History of neuropathy from causes other than diabetes as determined through medical and family history, physical and neurologic examinations * HbA1c \>10% * Participation in an experimental medication trial within 3 months of starting the study * Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer * Medical or psychiatric reason for not being a study candidate according to the site PI's discretion * Contraindications preventing trialing two interventions within any of the 3 modalities * Cirrhosis of the liver

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Conditions

The condition(s) this trial relates to.

diabetic kidney disease diabetic neuropathy

As listed by the trial registrant

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

Diabetic nephropathies Painful diabetic neuropathy (PDN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allina Health-Neurosciences Research

    Minneapolis, Minnesota, 55407, United States

  • BaylorScott & White University Medical Center

    McKinney, Texas, 75071, United States

  • Columbia University

    New York, New York, 10027, United States

  • DHR Health Institute for Research and Development

    Edinburg, Texas, 78539, United States

  • Duke University

    Durham, North Carolina, 27708, United States

  • Essentia Health

    Spooner, Wisconsin, 54801, United States

  • Johns Hopskins University

    Baltimore, Maryland, 21224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902, United States

  • Meharry Medical College

    Nashville, Tennessee, 37208, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Tulane University

    New Orleans, Louisiana, 70118, United States

  • University of Florida-Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48104, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Missouri

    Columbia, Missouri, 65201, United States

  • University of Nebraska

    Omaha, Nebraska, 68198, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh

    Titusville, Pennsylvania, 16354, United States

  • University of Vanderbilt

    Nashville, Tennessee, 37235, United States

  • Will Cornell Medicine

    New York, New York, 10065, United States

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