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

25. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

600

Fáze

Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Fallon Koenig, MS, CCRP
Telefonní číslo: 734-936-8778
E-mail: fakoenig@med.umich.edu

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: Randomizované
Intervenční model: Crossover Assignment
Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm Skupina účastníků / Arm Skupina nebo podskupina účastníků klinické studie, která podle protokolu studie dostává konkrétní intervenci/léčbu nebo žádnou intervenci.	Intervence / Léčba Intervence / Léčba Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.
Experimentální: 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.	Lék: 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
Experimentální: 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.	Lék: 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
Experimentální: 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.	Lék: 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 Lék: 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)
Experimentální: 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.	Lék: 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 Přístroj: 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).
Experimentální: 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.	Lék: 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)
Experimentální: 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.	Lék: 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)
Experimentální: 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.	Lék: 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 Lék: 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)
Experimentální: 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.	Lék: 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) Přístroj: 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).
Experimentální: 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.	Přístroj: 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).
Experimentální: 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.	Přístroj: 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).
Experimentální: 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.	Lék: 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 Přístroj: 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).
Experimentální: 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.	Lék: 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) Přístroj: 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).

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Patient-centered utility function as a measure for efficacy and tolerability Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Pain intensity Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Michigan

Spolupracovníci

Patient-Centered Outcomes Research Institute

Vyšetřovatelé

Vrchní vyšetřovatel: Brian Callaghan, MD, University of Michigan

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. srpna 2030

Dokončení studie (Odhadovaný)

1. srpna 2031

Termíny zápisu do studia

První předloženo

25. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

25. srpna 2026

První zveřejněno (Aktuální)

31. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

31. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

HUM00292431
BPS-2025C2-45514 (Jiné číslo grantu/financování: Patient-Centered Outcomes Research Institute (PCORI))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení IPD

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.

Typ podpůrných informací pro sdílení IPD

PROTOKOL STUDY
ICF
CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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