Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Public ClinicalTrials.gov record NCT07795593. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy (MCPAIN)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07795593
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 600 participants
Conditions and interventions
Interventions
- Cognitive Behavioral Therapy (CBT) Device
- Oral Medication Drug
- Topical Medication Drug
Device · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2026
- Primary completion
- Jul 31, 2030
- Completion
- Jul 31, 2031
- Last update posted
- Aug 30, 2026
2026 – 2031
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | — |
| University of Florida-Jacksonville | Jacksonville | Florida | 32209 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Tulane University | New Orleans | Louisiana | 70118 | — |
| Johns Hopskins University | Baltimore | Maryland | 21224 | — |
| University of Michigan | Ann Arbor | Michigan | 48104 | — |
| Allina Health-Neurosciences Research | Minneapolis | Minnesota | 55407 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | — |
| University of Missouri | Columbia | Missouri | 65201 | — |
| University of Nebraska | Omaha | Nebraska | 68198 | — |
| Columbia University | New York | New York | 10027 | — |
| Will Cornell Medicine | New York | New York | 10065 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Duke University | Durham | North Carolina | 27708 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| University of Pittsburgh | Titusville | Pennsylvania | 16354 | — |
| Meharry Medical College | Nashville | Tennessee | 37208 | — |
| University of Vanderbilt | Nashville | Tennessee | 37235 | — |
| DHR Health Institute for Research and Development | Edinburg | Texas | 78539 | — |
| BaylorScott & White University Medical Center | McKinney | Texas | 75071 | — |
| Essentia Health | Spooner | Wisconsin | 54801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07795593, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07795593 live on ClinicalTrials.gov.