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

ConditionsPainful Diabetic Neuropathy (PDN)Diabetic Nephropathies
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diabetes

Painful Diabetic Neuropathy (confirmed at screening visit)

Willing to accept random treatment assignment to any of the proposed interventions

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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 Medication

    Drug

    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 Medication

    Drug

    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)

Treatment groups

600 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Oral Medication then New Oral MedicationExperimental treatment 1 intervention
Group B: Oral Medication then Same Oral MedicationExperimental treatment 1 intervention
Group C: Oral Medication then Topical MedicationExperimental treatment 2 interventions
Group D: Oral Medication then Cognitive Behavioral TherapyExperimental treatment 2 interventions
Group E: Topical Medication then New Topical MedicationExperimental treatment 1 intervention
Group F: Topical Medication then Same Topical MedicationExperimental treatment 1 intervention
Group G: Topical Medication then Oral MedicationExperimental treatment 2 interventions
Group H: Topical Medication then Cognitive Behavioral TherapyExperimental treatment 2 interventions
Group I: Cognitive Behavioral Therapy then Same Cognitive Behavioral TherapyExperimental treatment 1 intervention
Group J: Cognitive Behavioral Therapy then New Cognitive Behavioral TherapyExperimental treatment 1 intervention
Group K: Cognitive Behavioral Therapy then Oral MedicationExperimental treatment 2 interventions
Group L: Cognitive Behavioral Therapy then Topical MedicationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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).

Time frame
Up to 8 months.

Secondary outcomes

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.

Time frame
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.

Time frame
Up to 8 months.
3

Discontinuation

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

Time frame
Up to 8 months
4

Related adverse events

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

Time frame
Up to 8 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: