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

Browse trials for

• Diabetic Neuropathies 538
• Diabetic Nephropathies 543

Diabetic Neuropathies

538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.

This study's planned enrollment of 600 is above the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Study 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.

  Drug: Oral Medication

• 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.

  Drug: Oral Medication

• 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.

  Drug: Oral Medication · Drug: Topical Medication

• 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.

  Device: Cognitive Behavioral Therapy (CBT) · Drug: Oral Medication

• 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.

  Drug: Topical Medication

• 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.

  Drug: Topical Medication

• 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.

  Drug: Oral Medication · Drug: Topical Medication

• 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.

  Device: Cognitive Behavioral Therapy (CBT) · Drug: Topical Medication

• 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.

  Device: Cognitive Behavioral Therapy (CBT)

• 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.

  Device: Cognitive Behavioral Therapy (CBT)

• 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.

  Device: Cognitive Behavioral Therapy (CBT) · Drug: Oral Medication

• 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.

  Device: Cognitive Behavioral Therapy (CBT) · Drug: Topical Medication

Interventions

• DeviceCognitive Behavioral Therapy (CBT)

  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).

• DrugOral Medication

  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

• DrugTopical Medication

  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)

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.

5. Physical functioning/Quality of Life (QOL)

   Physical function/QOL as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical functioning Short Form 6b, a 5 question questionnaire. Each question is measured with a likert scale, where 5 is "without any difficulty" and 1 is "unable to do"

   Time frame: Up to 8 months.

6. Neuropathy specific QOL

   Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life.

   Time frame: Up to 8 months

7. Depression

   As measured by the Patient Health Questionnaire (PHQ-2), a two-question questionnaire where each depression symptom is scored on a scale of 0-3, where 0 is "not at all" and 3 is "nearly every day". The total score range is 0-6 where the higher score indicates more depression symptoms.

   Time frame: Up to 8 months

8. Anxiety

   As measured by the General Anxiety Disorder (GAD-2), a two-question questionnaire where each anxiety symptom is scored on a scale of 0-3, where 0 is "not at all" and 3 is "nearly every day". The total score range is 0-6 where the higher score indicates more anxiety symptoms.

   Time frame: Up to 8 months

9. Sleep

   Sleep Quality represented by the sum of scores on the PROMIS Sleep Disturbance 6a and an additional question regarding sleep duration.

   Time frame: Up to 8 months

10. Pain Catastrophizing

    As measured by the Pain Catastrophizing Scale Short Form 6, where a score of 0 is catastrophizing "not at all" and 52 is catastrophizing "all the time"

    Time frame: Up to 8 months

11. Global treatment satisfaction

    As measured by Patient Global Impression of Change (PGIC), a single question on a scale of 0-6, where 0 is "very much improved" and 6 is "very much worse".

    Time frame: Up to 8 months

12. Substance use screener

    As measured by the Tobacco, Alcohol, Prescription Medications, and other Substance (TAPS 1) questionnaire, which is five questions on a scale of 0-4, where 0 is "daily or almost daily use" and 4 is "never use".

    Time frame: Up to 8 months

Individual participant data

Plan to share: Yes — Full, de-identified datasets will be deposited in a PCORI-designated repository at study completion. Study team will follow all rules and regulations of the funding agency, which can be found here: https://www.pcori.org/about/governance/pcoris-policy-data-management-and-data-sharing

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: At the time of publication of the research project's primary results in a peer-reviewed journal - for at least 7 years

Access criteria: A data requestor that submits a data request will be evaluated for its overall qualifications and experience (e.g., across a proposed team of specified individuals) to achieve the stated research purpose underlying the data request. Neither PCORI nor the Awardee investigators will provide technical assistance directly to data requestors. However, either party may provide input to the repository upon request.