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Painful Diabetic Neuropathy (PDN)Phase 4MCPAINNCT07795593

Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy

A Phase 4 study testing Cognitive Behavioral Therapy (CBT), Oral Medication and Topical Medication in people with Painful Diabetic Neuropathy (PDN) and Diabetic Nephropathies, run by University of Michigan at 23 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The research team will perform a comparative-effectiveness sequential, multiple assignment, randomized trial in painful diabetic neuropathy (PDN) patients for 8 total months, divided into two 4-month stages. 600 participants 18+ with PDN will be enrolled in this study. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cognitive Behavioral Therapy (CBT), Oral Medication and Topical Medication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
23 sitesUnited States
Study dates
Nov 2026to Jul 2031
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diabetes
  • Painful Diabetic Neuropathy (confirmed at screening visit)
  • Willing to accept random treatment assignment to any of the proposed interventions

Who cannot join

  • 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

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fallon Koenig, MS, CCRP contact

734-936-8778

fakoenig@med.umich.edu

23 sites in 1 country

United States23 sites

  • University of Michigan

    Ann Arbor, Michigan, 48104

    Shannon Considine, 734-232-6483, sconsidi@med.umich.edu

    Lynn Ang, MD

  • Johns Hopskins University

    Baltimore, Maryland, 21224

    Eva Tseng

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Elizabeth Burnett, Elizabeth_ODonohue@med.unc.edu

    Laura Young

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Bartosz Jacher, Bartosz_Jacher@rush.edu

    Rabia Malik

  • University of Missouri

    Columbia, Missouri, 65201

    Megan Burnam-Cole, burnamma@health.missouri.edu

    Richard Barohn

  • Duke University

    Durham, North Carolina, 27708

    Jhoanna Aquino, jhoannazaida.aquino@duke.edu

    Ranee Chatterjee, MD

  • DHR Health Institute for Research and Development

    Edinburg, Texas, 78539

    Clarisa Medina, c.medina@dhrhealth.com

    Marcel Twahirwa

  • University of Iowa

    Iowa City, Iowa, 52242

    Brian Gryzlak, brian-gryzlak@uiowa.edu

    Marcelo Correia

  • University of Florida-Jacksonville

    Jacksonville, Florida, 32209

    Grace Bienkowski, grace.bienkowski@jax.ufl.edu

    Joe Chehade

  • BaylorScott & White University Medical Center

    McKinney, Texas, 75071

    Priyanka Rana, Priyanka.Rana@BSWHealth.org

    Dana Bleakney

  • Allina Health-Neurosciences Research

    Minneapolis, Minnesota, 55407

    Emeryth Beloy, emeryth.beloy@allina.com

    Goel Vasudha

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Sarah Hilbert, hilbe010@umn.edu

    Pitcha Choompongpod

  • Meharry Medical College

    Nashville, Tennessee, 37208

    Abraham Garcia Ortega, agarcia@mmc.edu

    Nandakumar Bangalore Vittal, MD

  • University of Vanderbilt

    Nashville, Tennessee, 37235

    Allie Bell, allie.m.bell@vumc.org

    Amanda Peltier, MD

  • Tulane University

    New Orleans, Louisiana, 70118

    Vivian Fonseca

  • Columbia University

    New York, New York, 10027

    Raisy Fayerman, rf2632@cumc.columbia.edu

    Thomas Brannagan, MD

  • Weill Cornell Medicine

    New York, New York, 10065

    Michele Steinkamp, mls9004@med.cornell.edu

    Lisa Witkin

  • University of Nebraska

    Omaha, Nebraska, 68198

    Susan Bubach, susan.burbach@unmc.edu

    Lisa Kuechenmeister, likuechenmeister@nebraskamed.com

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Aly Carlson, carlsaly@ohsu.edu

    Rodica Busui

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902

    Kamal Shouman

  • Essentia Health

    Spooner, Wisconsin, 54801

    Nathan Mukai, nathan.mukai@essentiahealth.org

    Stephen Rostad

  • Stanford University

    Stanford, California, 94305

    Barbara Hung, barbhung@stanford.edu

    Dong In Sinn

  • University of Pittsburgh

    Titusville, Pennsylvania, 16354

    Autumn Boyer, ARB352@pitt.edu

    Emily Klawson, ekk15@pitt.edu

Other trials in United States

About this study

Official title: Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy (MCPAIN)

The research team will perform a comparative-effectiveness sequential, multiple assignment, randomized trial in painful diabetic neuropathy (PDN) patients for 8 total months, divided into two 4-month stages. 600 participants 18+ with PDN will be enrolled in this study. The main goal is to compare the utility of three modalities (oral, topical, and behavioral) for initial PDN treatment, and to compare the utility of switching modalities versus continuing with the same modality for non-responders. Pain and discontinuation will be assessed weekly, whereas other outcomes will be assessed monthly for 8 months.

Being tested
Cognitive Behavioral Therapy (CBT), Oral Medication, Topical Medication
Medical subject headings
Diabetic Neuropathies, Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy (CBT)Device

    Participants will work with study team to begin web-based, self-guided CBT (non-significant risk device) or traditional (one on one) CBT with a therapist (behavioral, not a device).

  • Oral MedicationDrug

    Participants will work with their physician to select an oral medication from a list commonly used to treat PDN. Patients will follow standard of care dosing and tapering of the assigned drug.

    Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's): Duloxetine, Venlafaxine, Desvenlafaxine Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline Gabapentinoids: Gabapentin, Pregabalin Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide

  • Topical MedicationDrug

    Participants will work with their physician to select a topical medication from a list commonly used to treat PDN.

    0.075% capsaicin cream (4 times daily) 4-5% lidocaine patches (1-4 patches every 24 hours)

Study groups in NCT07795593
Study groupRoleWhat they receive
Oral Medication then New Oral MedicationExperimentalParticipants randomized to oral medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select a new oral medication for the next 4 months.
Receives: Drug: Oral Medication
Oral Medication then Same Oral MedicationExperimentalParticipants randomized to oral medications, and are considered responders at 4 months will continue with the same oral medication for the next 4 months.
Receives: Drug: Oral Medication
Oral Medication then Topical MedicationExperimentalParticipants randomized to oral medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a topical medication for the next 4 months.
Receives: Drug: Oral Medication; Drug: Topical Medication
Oral Medication then Cognitive Behavioral TherapyExperimentalParticipants randomized to oral medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin self-guided CBT for the next 4 months.
Receives: Device: Cognitive Behavioral Therapy (CBT); Drug: Oral Medication
Topical Medication then New Topical MedicationExperimentalParticipants randomized to topical medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a new topical medication for the next 4 months.
Receives: Drug: Topical Medication
Topical Medication then Same Topical MedicationExperimentalParticipants randomized to topical medications, and are considered responders at 4 months will continue with the same topical medication for the next 4 months.
Receives: Drug: Topical Medication
Topical Medication then Oral MedicationExperimentalParticipants randomized to topical medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select an oral medication for the next 4 months.
Receives: Drug: Oral Medication; Drug: Topical Medication
Topical Medication then Cognitive Behavioral TherapyExperimentalParticipants randomized to topical medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin self-guided CBT for the next 4 months.
Receives: Device: Cognitive Behavioral Therapy (CBT); Drug: Topical Medication
Cognitive Behavioral Therapy then Same Cognitive Behavioral TherapyExperimentalParticipants randomized to behavioral interventions will all begin with self-guided CBT. If considered responders at 4 months they will continue with self-guided CBT for the next 4 months.
Receives: Device: Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy then New Cognitive Behavioral TherapyExperimentalParticipants randomized to behavioral interventions will all begin with self-guided CBT. If considered non-responders at 4 months, they will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin traditional CBT for the next 4 months.
Receives: Device: Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy then Oral MedicationExperimentalParticipants randomized to behavioral interventions will all begin with self-guided CBT. Non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select an oral medication for the next 4 months.
Receives: Device: Cognitive Behavioral Therapy (CBT); Drug: Oral Medication
Cognitive Behavioral Therapy then Topical MedicationExperimentalParticipants randomized to behavioral interventions will all begin with self-guided CBT. Non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a topical medication for the next 4 months.
Receives: Device: Cognitive Behavioral Therapy (CBT); Drug: Topical Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-centered utility function as a measure for efficacy and tolerability

    Efficacy and tolerability will be assessed and measured as utility function. Utility function ranges from 0-1.75, 0 being the lowest utility function and 1.75 being the highest utility function. Utility function that is a composite of efficacy (0-1) and discontinuation (0-1).

    Measured: Up to 8 months.

Secondary outcomes (12)

  1. Pain intensity

    Pain intensity as measured by first question of the "Pain, Enjoyment, General Activity" (PEG) numeric rating scale, where a score of 0 is no pain and 10 is the worst pain imaginable.

    Measured: Up to 8 months.

  2. Pain interference

    Pain interference as measured by the sum of the second two questions of the "Pain, Enjoyment, General Activity" (PEG) numeric rating scale, where a score of 0 is no interference with daily life and 20 is the complete interference with daily life.

    Measured: Up to 8 months.

  3. Discontinuation

    Rate of treatment discontinuation for any reason, including withdrawal From enrollment to end of treatment at 8 months.

    Measured: Up to 8 months

  4. Related adverse events

    Adverse events reported by local sites and determined to be related to the treatment.

    Measured: Up to 8 months.

  5. Physical functioning/Quality of Life (QOL)

    Physical function/QOL as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical functioning Short Form 6b, a 5 question questionnaire. Each question is measured with a likert scale, where 5 is "without any difficulty" and 1 is "unable to do"

    Measured: Up to 8 months.

  6. Neuropathy specific QOL

    Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life.

    Measured: Up to 8 months

  7. Depression

    As measured by the Patient Health Questionnaire (PHQ-2), a two-question questionnaire where each depression symptom is scored on a scale of 0-3, where 0 is "not at all" and 3 is "nearly every day". The total score range is 0-6 where the higher score indicates more depression symptoms.

    Measured: Up to 8 months

  8. Anxiety

    As measured by the General Anxiety Disorder (GAD-2), a two-question questionnaire where each anxiety symptom is scored on a scale of 0-3, where 0 is "not at all" and 3 is "nearly every day". The total score range is 0-6 where the higher score indicates more anxiety symptoms.

    Measured: Up to 8 months

  9. Sleep

    Sleep Quality represented by the sum of scores on the PROMIS Sleep Disturbance 6a and an additional question regarding sleep duration.

    Measured: Up to 8 months

  10. Pain Catastrophizing

    As measured by the Pain Catastrophizing Scale Short Form 6, where a score of 0 is catastrophizing "not at all" and 52 is catastrophizing "all the time"

    Measured: Up to 8 months

  11. Global treatment satisfaction

    As measured by Patient Global Impression of Change (PGIC), a single question on a scale of 0-6, where 0 is "very much improved" and 6 is "very much worse".

    Measured: Up to 8 months

  12. Substance use screener

    As measured by the Tobacco, Alcohol, Prescription Medications, and other Substance (TAPS 1) questionnaire, which is five questions on a scale of 0-4, where 0 is "daily or almost daily use" and 4 is "never use".

    Measured: Up to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionMay 2031 (estimated)
  4. Study completionJul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
a comparative-effectiveness sequential, multiple assignment, randomized trial
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07795593
Sponsor's protocol ID
HUM00292431
Other IDs
BPS-2025C2-45514
Acronym
MCPAIN
Status last verified
Oct 2026
First submitted
25 Aug 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: Full, de-identified datasets will be deposited in a PCORI-designated repository at study completion. Study team will follow all rules and regulations of the funding agency, which can be found here: https://www.pcori.org/about/governance/pcoris-policy-data-management-and-data-sharing

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cognitive Behavioral Therapy (CBT), Oral Medication and Topical Medication in people with Painful Diabetic Neuropathy (PDN) and Diabetic Nephropathies, run by University of Michigan at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fallon Koenig, MS, CCRP (734-936-8778, fakoenig@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-centered utility function as a measure for efficacy and tolerability (time frame: Up to 8 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07795593.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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