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

25. august 2026 opdateret af: Brian Callaghan, University of Michigan

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

600

Fase

Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Fallon Koenig, MS, CCRP
Telefonnummer: 734-936-8778
E-mail: fakoenig@med.umich.edu

Studiesteder

Forenede Stater
- California
  - Stanford, California, Forenede Stater, 94305
    - Stanford University
    - Kontakt:
      
      Barbara Hung
      
      E-mail: barbhung@stanford.edu
    - Ledende efterforsker:
      
      Dong In Sinn
- Florida
  - Jacksonville, Florida, Forenede Stater, 32209
    - University of Florida-Jacksonville
    - Kontakt:
      
      Grace Bienkowski
      
      E-mail: grace.bienkowski@jax.ufl.edu
    - Ledende efterforsker:
      
      Joe Chehade
- Illinois
  - Chicago, Illinois, Forenede Stater, 60612
    - Rush University Medical Center
    - Kontakt:
      
      Bartosz Jacher
      
      E-mail: Bartosz_Jacher@rush.edu
    - Ledende efterforsker:
      
      Rabia Malik
- Iowa
  - Iowa City, Iowa, Forenede Stater, 52242
    - University of Iowa
    - Ledende efterforsker:
      
      Marcelo Correia
    - Kontakt:
      
      Brian Gryzlak
      
      E-mail: brian-gryzlak@uiowa.edu
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70118
    - Tulane University
    - Ledende efterforsker:
      
      Vivian Fonseca
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21224
    - Johns Hopskins University
    - Ledende efterforsker:
      
      Eva Tseng
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48104
    - University of Michigan
    - Ledende efterforsker:
      
      Lynn Ang, MD
    - Kontakt:
      
      Fallon Koenig, MS, CCRP
      
      Telefonnummer: 734-936-8778
      
      E-mail: fakoenig@med.umich.edu
- Minnesota
  - Minneapolis, Minnesota, Forenede Stater, 55455
    - University of Minnesota
    - Kontakt:
      
      Sarah Hilbert
      
      E-mail: hilbe010@umn.edu
    - Ledende efterforsker:
      
      Pitcha Choompongpod
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Allina Health-Neurosciences Research
    - Kontakt:
      
      Emeryth Beloy
      
      E-mail: emeryth.beloy@allina.com
    - Ledende efterforsker:
      
      Goel Vasudha
  - Rochester, Minnesota, Forenede Stater, 55902
    - Mayo Clinic Rochester
    - Ledende efterforsker:
      
      Kamal Shouman
- Missouri
  - Columbia, Missouri, Forenede Stater, 65201
    - University of Missouri
    - Kontakt:
      
      Megan Burnam-Cole
      
      E-mail: burnamma@health.missouri.edu
    - Ledende efterforsker:
      
      Benjamin Crenshaw
- Nebraska
  - Omaha, Nebraska, Forenede Stater, 68198
    - University of Nebraska
    - Ledende efterforsker:
      
      Cyrus Desouza
    - Kontakt:
      
      Susan Bubach
      
      E-mail: susan.burbach@unmc.edu
    - Kontakt:
      
      Lisa Kuechenmeister
      
      E-mail: likuechenmeister@nebraskamed.com
- New York
  - New York, New York, Forenede Stater, 10027
    - Columbia University
  - New York, New York, Forenede Stater, 10065
    - Will Cornell Medicine
    - Kontakt:
      
      Michele Steinkamp
      
      E-mail: mls9004@med.cornell.edu
    - Ledende efterforsker:
      
      Lisa Witkin
- North Carolina
  - Chapel Hill, North Carolina, Forenede Stater, 27599
    - University of North Carolina
    - Kontakt:
      
      Elizabeth Burnett
      
      E-mail: Elizabeth_ODonohue@med.unc.edu
    - Ledende efterforsker:
      
      Laura Young
  - Durham, North Carolina, Forenede Stater, 27708
    - Duke University
    - Ledende efterforsker:
      
      Ranee Chatterjee, MD
    - Kontakt:
      
      Jhoanna Aquino
      
      E-mail: jhoannazaida.aquino@duke.edu
- Oregon
  - Portland, Oregon, Forenede Stater, 97239
    - Oregon Health & Science University
    - Ledende efterforsker:
      
      Rodica Busui
    - Kontakt:
      
      Aly Carlson
      
      E-mail: carlsaly@ohsu.edu
- Pennsylvania
  - Titusville, Pennsylvania, Forenede Stater, 16354
    - University of Pittsburgh
    - Kontakt:
      
      Autumn Boyer
      
      E-mail: ARB352@pitt.edu
    - Kontakt:
      
      Emily Klawson
      
      E-mail: ekk15@pitt.edu
    - Ledende efterforsker:
      
      Holly Thomas
- Tennessee
  - Nashville, Tennessee, Forenede Stater, 37208
    - Meharry Medical College
    - Kontakt:
      
      Abraham Garcia Ortega
      
      E-mail: agarcia@mmc.edu
  - Nashville, Tennessee, Forenede Stater, 37235
    - University of Vanderbilt
- Texas
  - Edinburg, Texas, Forenede Stater, 78539
    - DHR Health Institute for Research and Development
    - Kontakt:
      
      Clarisa Medina
      
      E-mail: c.medina@dhrhealth.com
    - Ledende efterforsker:
      
      Marcel Twahirwa
  - McKinney, Texas, Forenede Stater, 75071
    - BaylorScott & White University Medical Center
    - Kontakt:
      
      Priyanka Rana
      
      E-mail: Priyanka.Rana@BSWHealth.org
    - Ledende efterforsker:
      
      Dana Bleakney
- Wisconsin
  - Spooner, Wisconsin, Forenede Stater, 54801
    - Essentia Health
    - Kontakt:
      
      Nathan Mukai
      
      E-mail: nathan.mukai@essentiahealth.org
    - Ledende efterforsker:
      
      Stephen Rostad

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Crossover opgave
Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Oral Medication then New Oral Medication Participants 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.	Medicin: Oral Medication 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
Eksperimentel: Oral Medication then Same Oral Medication Participants randomized to oral medications, and are considered responders at 4 months will continue with the same oral medication for the next 4 months.	Medicin: Oral Medication 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
Eksperimentel: Oral Medication then Topical Medication Participants 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.	Medicin: Oral Medication 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 Medicin: Topical Medication 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)
Eksperimentel: Oral Medication then Cognitive Behavioral Therapy Participants 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.	Medicin: Oral Medication 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 Enhed: Cognitive Behavioral Therapy (CBT) 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).
Eksperimentel: Topical Medication then New Topical Medication Participants 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.	Medicin: Topical Medication 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)
Eksperimentel: Topical Medication then Same Topical Medication Participants randomized to topical medications, and are considered responders at 4 months will continue with the same topical medication for the next 4 months.	Medicin: Topical Medication 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)
Eksperimentel: Topical Medication then Oral Medication Participants 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.	Medicin: Oral Medication 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 Medicin: Topical Medication 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)
Eksperimentel: Topical Medication then Cognitive Behavioral Therapy Participants 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.	Medicin: Topical Medication 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) Enhed: Cognitive Behavioral Therapy (CBT) 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).
Eksperimentel: Cognitive Behavioral Therapy then Same Cognitive Behavioral Therapy Participants 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.	Enhed: Cognitive Behavioral Therapy (CBT) 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).
Eksperimentel: Cognitive Behavioral Therapy then New Cognitive Behavioral Therapy Participants 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.	Enhed: Cognitive Behavioral Therapy (CBT) 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).
Eksperimentel: Cognitive Behavioral Therapy then Oral Medication Participants 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.	Medicin: Oral Medication 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 Enhed: Cognitive Behavioral Therapy (CBT) 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).
Eksperimentel: Cognitive Behavioral Therapy then Topical Medication Participants 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.	Medicin: Topical Medication 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) Enhed: Cognitive Behavioral Therapy (CBT) 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Patient-centered utility function as a measure for efficacy and tolerability Tidsramme: Up to 8 months.	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).	Up to 8 months.

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Pain intensity Tidsramme: Up to 8 months.	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.	Up to 8 months.
Pain interference Tidsramme: Up to 8 months.	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.	Up to 8 months.
Discontinuation Tidsramme: Up to 8 months	Rate of treatment discontinuation for any reason, including withdrawal From enrollment to end of treatment at 8 months.	Up to 8 months
Related adverse events Tidsramme: Up to 8 months.	Adverse events reported by local sites and determined to be related to the treatment.	Up to 8 months.
Physical functioning/Quality of Life (QOL) Tidsramme: Up to 8 months.	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"	Up to 8 months.
Neuropathy specific QOL Tidsramme: Up to 8 months	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.	Up to 8 months
Depression Tidsramme: Up to 8 months	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.	Up to 8 months
Anxiety Tidsramme: Up to 8 months	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.	Up to 8 months
Sleep Tidsramme: Up to 8 months	Sleep Quality represented by the sum of scores on the PROMIS Sleep Disturbance 6a and an additional question regarding sleep duration.	Up to 8 months
Pain Catastrophizing Tidsramme: Up to 8 months	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"	Up to 8 months
Global treatment satisfaction Tidsramme: Up to 8 months	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".	Up to 8 months
Substance use screener Tidsramme: Up to 8 months	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".	Up to 8 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Michigan

Samarbejdspartnere

Patient-Centered Outcomes Research Institute

Efterforskere

Ledende efterforsker: Brian Callaghan, MD, University of Michigan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. august 2030

Studieafslutning (Anslået)

1. august 2031

Datoer for studieregistrering

Først indsendt

25. august 2026

Først indsendt, der opfyldte QC-kriterier

25. august 2026

Først opslået (Faktiske)

31. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

HUM00292431
BPS-2025C2-45514 (Andet bevillings-/finansieringsnummer: Patient-Centered Outcomes Research Institute (PCORI))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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

IPD-delingstidsramme

At the time of publication of the research project's primary results in a peer-reviewed journal - for at least 7 years

IPD-delingsadgangskriterier

A data requestor that submits a data request will be evaluated for its overall qualifications and experience (e.g., across a proposed team of specified individuals) to achieve the stated research purpose underlying the data request. Neither PCORI nor the Awardee investigators will provide technical assistance directly to data requestors. However, either party may provide input to the repository upon request.

IPD-deling Understøttende informationstype

STUDY_PROTOCOL
ICF
CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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