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

Conditions

• Diabetic Nephropathies
• Painful Diabetic Neuropathy (PDN)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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)

Study Details

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.

Key Dates

First listed

Aug 31, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2030

Completion

Aug 31, 2031

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

Patient-centered utility function as a measure for efficacy and tolerability [ Time Frame: Up to 8 months. ]

Central Contacts

• Fallon Koenig, MS, CCRP
  734-936-8778
  [email protected]

Locations (23)

Find similar trials in Stanford, CA

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