drugset / Trial / NCT07795593
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Phase 4
Not yet recruiting
600 enrolled
University of Michigan
Patient-Centered Outcomes Research Institute · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2026-10
- Primary completion
- 2031-05
- Completion
- 2031-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amitriptyline | Small molecule | — | Oral |
| Subject | Capsaicin | Small molecule | 0.075 % | Topical |
| Subject | Desvenlafaxine | Other / unclassified | — | Oral |
| Subject | Duloxetine | Small molecule | — | Oral |
| Subject | Gabapentin | Unknown | — | Oral |
| Subject | Lacosamide | Other / unclassified | — | Oral |
| Subject | Lamotrigine | Small molecule | — | Oral |
| Subject | Lidocaine | Other / unclassified | 4 % | Topical |
| Subject | Lidocaine | Other / unclassified | 5 % | Topical |
| Subject | Nortriptyline | Small molecule | — | Oral |
| Subject | Oxcarbazepine | Small molecule | — | Oral |
| Subject | Pregabalin | Small molecule | — | Oral |
| Subject | Venlafaxine | Small molecule | — | Oral |