SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease (NCT06480786)
Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy and Peripheral Arterial Disease: Mechanistic Insights From a Single-center, Randomized, Blinded, Sham-controlled Cross-over Proof-of-concept Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Nebraska Medical Center — Omaha, Nebraska
Age range: 19 Years to 89 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Nebraska Medical Center — Omaha, Nebraska
📞 Contact the Study Coordinator
Phone: (402) 552-3077
Email: outcomesresearch@unmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Peripheral Arterial Disease
- SELUTION4SFA Trial — Little Rock, Arkansas
- SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs — New Haven, Connecticut
- A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND) — Birmingham, Alabama
- Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy — Indianapolis, Indiana
- FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease — Chicago, Illinois
- MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology — Omaha, Nebraska
Explore by condition: All Peripheral Arterial Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.