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

ClinicalTrials.gov ID

NCT07795593

Lead Sponsor

University of MichiganOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

600Estimated

Last Update Posted

Aug 31, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Aug 2030Estimated

Completion Date

Aug 2031Estimated

Official Title

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

Brief 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. 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.

• Painful Diabetic Neuropathy (PDN)
• Diabetic Nephropathies

• Cognitive Behavioral Therapy (CBT)
• Oral Medication
• Topical Medication

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

University of MichiganOTHER

Collaborators

Patient-Centered Outcomes Research InstituteOTHER

grace.bienkowski@jax.ufl.edu

Bartosz_Jacher@rush.edu

brian-gryzlak@uiowa.edu

fakoenig@med.umich.edu734-936-8778

emeryth.beloy@allina.com

hilbe010@umn.edu

burnamma@health.missouri.edu

susan.burbach@unmc.edu

mls9004@med.cornell.edu

Elizabeth_ODonohue@med.unc.edu

jhoannazaida.aquino@duke.edu

carlsaly@ohsu.edu

ARB352@pitt.edu

agarcia@mmc.edu

c.medina@dhrhealth.com

Priyanka.Rana@BSWHealth.org

nathan.mukai@essentiahealth.org

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