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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: Recruiting NA study of Diabetes Mellitus, Type 2 and Chronic Pain, sponsored by University of Nebraska.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The visual analogue scale (VAS) will be used by participants to report lower extremity pain during interventions. The VAS score is a10-cm line that represents a continuum between "no pain" and "worst pain."
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 |
What NCT06480786 shows while recruiting
NCT06480786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06480786's enrollment target sits among peer trials
15 336th of 348 higher than 11 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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