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NCT06480786 · ClinicalTrials.gov registry record · NA
SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
A NA study of Diabetes Mellitus, Type 2 and Chronic Pain, sponsored by University of Nebraska.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06480786 is a NA study of Diabetes Mellitus, Type 2 and Chronic Pain that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 15 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06480786, a NA study of Diabetes Mellitus, Type 2 and Chronic Pain, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which is unresponsive to traditional pharmacotherapy, limits the patient's tolerance to exercise, which is an important disease-modifying intervention. Spinal cord stimulation is a well-established therapy for medically intractable pain, including painful diabetic neuropathy (PDN) and ischemic pain, but is not part of the standard-of-care for PAD despite limited promising clinical data. Early studies used first-generation, tonic stimulation devices, but with these it was impossible to perform sham-controlled trials to test the treatment. Since then, new types of waveform treatments, including high-frequency spinal cord stimulation (SCS), have been shown to be more effective in the treatment of intractable pain. While high-frequency SCS is approved for PDN treatment, it has never been tested in the treatment of claudication pain from PAD. This study will enroll up to 15 participants between the ages of 19 and 89 who have PAD and PDN and are successfully implanted with a permanent SCS. Twelve weeks after SCS implantation, participants will receive two weeks of stimulation and two weeks of sham intervention, in random starting order. Blood flow, blood pressure, skin oxygen levels, and participant reported pain int the lower extremities will be assessed before SCS implantation, 12 weeks after SCS implantation and during each of the treatment periods. Participants will also complete a quality of life survey at the same time points. Comparisons of these measurements with the baseline and post-implantation measurements to determine the effects of SCS.
Conditions Studied
Interventions
- DEVICE Sham stimulation
- DEVICE Spinal cord stimulation
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-12-18 |
| Est. Completion | 2027-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06480786
The ClinicalTrials.gov registry entry for NCT06480786 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Sham stimulation is the first listed.
NCT06480786 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT06480786 about?
NCT06480786 is a clinical study titled "SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease". Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which i...
What is the current status of trial NCT06480786?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2024-12-18. Estimated completion is 2027-07.
What conditions does trial NCT06480786 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Chronic Pain, Peripheral Arterial Disease, Chronic Pain Syndrome, Painful Diabetic Neuropathy.
What interventions are being tested in trial NCT06480786?
The interventions under investigation include: Sham stimulation (DEVICE), Spinal cord stimulation (DEVICE).
Who is sponsoring clinical trial NCT06480786?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06480786 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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