Peripheral Arterial DiseaseNCT06480786
SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
A study testing Spinal cord stimulation in people with Peripheral Arterial Disease and Painful Diabetic Neuropathy, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 89 years
- Conditions the study is for
- Peripheral Arterial Disease, Painful Diabetic Neuropathy, Diabetes Mellitus, Type 2
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years to 89 years old
- Diagnosed diabetes mellitus
- Signs or symptoms of neuropathy and maximum baseline visual-analog pain scale ≥ 5 cm and peripheral arterial disease (diagnosed by ankle-brachial index < 0.90 or vascular imaging studies) with claudication and exertion-induced visual-analog pain scale ≥ 6 cm for a minimum of 3 months
- Successful spinal cord stimulator (SCS) trial (>50% relief of chronic lower extremity pain) and will have a new permanent SCS placed prior to study intervention
Who cannot join
- Uncontrolled psychological or psychiatric disorder
- Inability to hold antithrombotic therapy per the American Society of Regional Anesthesia guidelines
- Non-healing wounds
- Gangrene
- Critical limb ischemia
- Prior lower extremity amputation
Show all 9Show fewer
- Inability to adhere to study follow-up
- Mechanical spine instability based on flexion/extension radiographs of the lumbar spine
- Prior or current spinal cord stimulator implant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Michael Lankhorst, MD, 402-596-4200, michael.lankhorst@unmc.edu
About this study
Official title: 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
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.
Read the detailed description
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 (ankle-brachial index under 0.90 or vascular imaging, and experience pain from walking with a pain level of at least 6 cm for at least 3 months )and PDN and who meet inclusion criteria for permanent spinal cord stimulator (SCS) placement. Participants must also have diabetes with symptoms of neuropathy, have a starting pain level of at least 5 cm on a visual pain scale and Vascular Quality of Life Questionnaire score of 5.5 or less.
The study begins with an initial evaluation visit, then a follow-up visit 12 weeks after permanent SCS implantation and optimization. Participants will then be randomized to start in the SCS group or the sham intervention group. Each of these interventions will be conducted for two weeks, then participants will switch to the other intervention in a cross over design. 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. The study intervention lasts for 4 weeks, after which participants will return to standard SCS care.
- Conditions
- Peripheral Arterial Disease, Painful Diabetic Neuropathy, Diabetes Mellitus, Type 2, Chronic Pain, Spinal Cord Stimulation, Chronic Pain Syndrome
- Being tested
- Spinal cord stimulation, Sham stimulation
- Medical subject headings
- Peripheral Arterial Disease, Diabetic Neuropathies, Diabetes Mellitus, Type 2, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationDevice
active spinal cord stimulation
Sham stimulationDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active Spinal Cord Stimulation | Experimental | Therapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice. Receives: Device: Spinal cord stimulation |
| Sham Stimulation | Sham comparator | Sub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-frequency Spinal Cord Stimulation Effect on Analgesia
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."
Measured: Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
Secondary outcomes (3)
High-frequency Spinal Cord Stimulation Effect on Quality of Life
Quality of life changes from high-frequency high-frequency spinal cord stimulation (SCS) will be measured by the Vascular Quality of Life Questionnaire (VASCUQOL). This instrument has 25 questions covering pain, symptoms, activities, social, and emotional. Each question has seven responses from 1 (worst) to 7 (best).
Measured: Baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
High-frequency Spinal Cord Stimulation Effect on Blood Flow
Changes in blood flow from high-frequency spinal cord stimulation (SCS) will measure lower extremity capillary digit blood flow flow by laser speckle imaging.
Measured: Baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
High-frequency Spinal Cord Stimulation Effect on Autonomic Control
Changes in autonomic control from high-frequency spinal cord stimulation (SCS) will measure sympathetic vasomotion by volume-clamp method on digits of the hand and laser speckle imaging on the lower extremities.
Measured: Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start18 Dec 2024
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1:1 cross over design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Nevro Corp
- Responsible party
- Sponsor
- Investigators
- Peter Pellegrino, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480786
- Sponsor's protocol ID
- 0623-24-FB
- Status last verified
- Oct 2025
- First submitted
- 24 Jun 2024
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.
PubMed 33818600Pellegrino PR, Zucker IH, Chatzizisis YS, Wang HJ, Schiller AM. Quantification of Renal Sympathetic Vasomotion as a Novel End Point for Renal Denervation. Hypertension. 2020 Oct;76(4):1247-1255. doi: 10.1161/HYPERTENSIONAHA.120.15325. Epub 2020 Aug 24.
PubMed 32829663Al-Kaisy A, Palmisani S, Pang D, Sanderson K, Wesley S, Tan Y, McCammon S, Trescott A. Prospective, Randomized, Sham-Control, Double Blind, Crossover Trial of Subthreshold Spinal Cord Stimulation at Various Kilohertz Frequencies in Subjects Suffering From Failed Back Surgery Syndrome (SCS Frequency Study). Neuromodulation. 2018 Jul;21(5):457-465. doi: 10.1111/ner.12771. Epub 2018 Apr 2.
PubMed 29608229Kretzschmar M, Okaro U, Schwarz M, Reining M, Lesser T. Spinal Neuromodulation for Peripheral Arterial Disease of Lower Extremities: A Ten-Year Retrospective Analysis. Neuromodulation. 2024 Oct;27(7):1240-1250. doi: 10.1016/j.neurom.2023.10.186. Epub 2024 Jan 1.
PubMed 38165292Piedade GS, Vesper J, Reichstein D, Dauphin AK, Damirchi S. Spinal cord stimulation in non-reconstructable critical limb ischemia: a retrospective study of 71 cases. Acta Neurochir (Wien). 2023 Apr;165(4):967-973. doi: 10.1007/s00701-022-05448-8. Epub 2023 Jan 4.
PubMed 36598544Klinkova A, Kamenskaya O, Ashurkov A, Murtazin V, Orlov K, Lomivorotov VV, Karaskov A. The Clinical Outcomes in Patients with Critical Limb Ischemia One Year after Spinal Cord Stimulation. Ann Vasc Surg. 2020 Jan;62:356-364. doi: 10.1016/j.avsg.2018.12.093. Epub 2019 Feb 22.
PubMed 30802587Deogaonkar M, Zibly Z, Slavin KV. Spinal cord stimulation for the treatment of vascular pathology. Neurosurg Clin N Am. 2014 Jan;25(1):25-31. doi: 10.1016/j.nec.2013.08.013. Epub 2013 Oct 5.
PubMed 24262897Petrakis E, Sciacca V. Prospective study of transcutaneous oxygen tension (TcPO2) measurement in the testing period of spinal cord stimulation in diabetic patients with critical lower limb ischaemia. Int Angiol. 2000 Mar;19(1):18-25.
PubMed 10853681Chapman KB, Kloosterman J, Schor JA, Girardi GE, van Helmond N, Yousef TA. Objective Improvements in Peripheral Arterial Disease from Dorsal Root Ganglion Stimulation: A Case Series. Ann Vasc Surg. 2021 Jul;74:519.e7-519.e16. doi: 10.1016/j.avsg.2021.01.069. Epub 2021 Feb 4.
PubMed 33549777De Caridi G, Massara M, David A, Giardina M, La Spada M, Stilo F, Spinelli F, Grande R, Butrico L, de Franciscis S, Serra R. Spinal cord stimulation to achieve wound healing in a primary lower limb critical ischaemia referral centre. Int Wound J. 2016 Apr;13(2):220-5. doi: 10.1111/iwj.12272. Epub 2014 Apr 8.
PubMed 24712687Cucuruz B, Kopp R, Hampe-Hecht H, Andercou O, Schierling W, Pfister K, Koller M, Noppeney T. Treatment of end-stage peripheral artery disease by neuromodulation. Clin Hemorheol Microcirc. 2022;81(4):315-324. doi: 10.3233/CH-221436.
PubMed 35466931Cyrek AE, Henn N, Meinhardt F, Lainka M, Pacha A, Paul A, Koch D. Improving Limb Salvage for Chronic Limb-Threatening Ischemia With Spinal Cord Stimulation: A Retrospective Analysis. Vasc Endovascular Surg. 2021 May;55(4):367-373. doi: 10.1177/1538574420985765. Epub 2021 Feb 8.
PubMed 33550918Petrakis IE, Sciacca V. Does autonomic neuropathy influence spinal cord stimulation therapy success in diabetic patients with critical lower limb ischemia? Surg Neurol. 2000 Feb;53(2):182-8; discussion 188-9. doi: 10.1016/s0090-3019(99)00182-2.
PubMed 10713199Kilchukov M, Kiselev R, Gorbatykh A, Klinkova A, Murtazin V, Kamenskaya O, Orlov K. High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial. Stereotact Funct Neurosurg. 2023;101(1):1-11. doi: 10.1159/000527309. Epub 2023 Jan 6.
PubMed 36617410Abu Dabrh AM, Steffen MW, Asi N, Undavalli C, Wang Z, Elamin MB, Conte MS, Murad MH. Nonrevascularization-based treatments in patients with severe or critical limb ischemia. J Vasc Surg. 2015 Nov;62(5):1330-9.e13. doi: 10.1016/j.jvs.2015.07.069. Epub 2015 Sep 26.
PubMed 26409842
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06480786
- Acronym / sponsor ID
- 0623-24-FB
- Conditions
- Peripheral Arterial Disease, Painful Diabetic Neuropathy, Diabetes Mellitus, Type 2, Chronic Pain, Spinal Cord Stimulation, Chronic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Nevro Corp
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 (ankle-brachial index under 0.90 or vascular imaging, and experience pain from walking with a pain level of at least 6 cm for at least 3 months )and PDN and who meet inclusion criteria for permanent spinal cord stimulator (SCS) placement. Participants must also have diabetes with symptoms of neuropathy, have a starting pain level of at least 5 cm on a visual pain scale and Vascular Quality of Life Questionnaire score of 5.5 or less.
The study begins with an initial evaluation visit, then a follow-up visit 12 weeks after permanent SCS implantation and optimization. Participants will then be randomized to start in the SCS group or the sham intervention group. Each of these interventions will be conducted for two weeks, then participants will switch to the other intervention in a cross over design. 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. The study intervention lasts for 4 weeks, after which participants will return to standard SCS care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1:1 cross over design
| Arm | Type | Receives |
|---|---|---|
| Active Spinal Cord Stimulation | Experimental | Device: Spinal cord stimulationTherapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice. |
| Sham Stimulation | Sham comparator | Device: Sham stimulationSub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control. |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19 years to 89 years old
- Diagnosed diabetes mellitus
- Signs or symptoms of neuropathy and maximum baseline visual-analog pain scale ≥ 5 cm and peripheral arterial disease (diagnosed by ankle-brachial index < 0.90 or vascular imaging studies) with claudication and exertion-induced visual-analog pain scale ≥ 6 cm for a minimum of 3 months
- Successful spinal cord stimulator (SCS) trial (>50% relief of chronic lower extremity pain) and will have a new permanent SCS placed prior to study intervention
Key exclusion criteria (9 listed)
- Uncontrolled psychological or psychiatric disorder
- Inability to hold antithrombotic therapy per the American Society of Regional Anesthesia guidelines
- Non-healing wounds
- Gangrene
- Critical limb ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulationactive spinal cord stimulation | Device | Active Spinal Cord Stimulation |
| Sham stimulationSham stimulation | Device | Sham Stimulation |
Primary outcome
High-frequency Spinal Cord Stimulation Effect on Analgesia
Time frame: Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
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."
3 secondary outcomes
High-frequency Spinal Cord Stimulation Effect on Quality of Life
Time frame: Baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
High-frequency Spinal Cord Stimulation Effect on Blood Flow
Time frame: Baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
High-frequency Spinal Cord Stimulation Effect on Autonomic Control
Time frame: Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Background: PubMed 33818600Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.
- Background: PubMed 32829663Pellegrino PR, Zucker IH, Chatzizisis YS, Wang HJ, Schiller AM. Quantification of Renal Sympathetic Vasomotion as a Novel End Point for Renal Denervation. Hypertension. 2020 Oct;76(4):1247-1255. doi: 10.1161/HYPERTENSIONAHA.120.15325. Epub 2020 Aug 24.
- Background: PubMed 29608229Al-Kaisy A, Palmisani S, Pang D, Sanderson K, Wesley S, Tan Y, McCammon S, Trescott A. Prospective, Randomized, Sham-Control, Double Blind, Crossover Trial of Subthreshold Spinal Cord Stimulation at Various Kilohertz Frequencies in Subjects Suffering From Failed Back Surgery Syndrome (SCS Frequency Study). Neuromodulation. 2018 Jul;21(5):457-465. doi: 10.1111/ner.12771. Epub 2018 Apr 2.
- Background: PubMed 38165292Kretzschmar M, Okaro U, Schwarz M, Reining M, Lesser T. Spinal Neuromodulation for Peripheral Arterial Disease of Lower Extremities: A Ten-Year Retrospective Analysis. Neuromodulation. 2024 Oct;27(7):1240-1250. doi: 10.1016/j.neurom.2023.10.186. Epub 2024 Jan 1.
- Background: PubMed 36598544Piedade GS, Vesper J, Reichstein D, Dauphin AK, Damirchi S. Spinal cord stimulation in non-reconstructable critical limb ischemia: a retrospective study of 71 cases. Acta Neurochir (Wien). 2023 Apr;165(4):967-973. doi: 10.1007/s00701-022-05448-8. Epub 2023 Jan 4.
- Background: PubMed 30802587Klinkova A, Kamenskaya O, Ashurkov A, Murtazin V, Orlov K, Lomivorotov VV, Karaskov A. The Clinical Outcomes in Patients with Critical Limb Ischemia One Year after Spinal Cord Stimulation. Ann Vasc Surg. 2020 Jan;62:356-364. doi: 10.1016/j.avsg.2018.12.093. Epub 2019 Feb 22.
- Background: PubMed 24262897Deogaonkar M, Zibly Z, Slavin KV. Spinal cord stimulation for the treatment of vascular pathology. Neurosurg Clin N Am. 2014 Jan;25(1):25-31. doi: 10.1016/j.nec.2013.08.013. Epub 2013 Oct 5.
- Background: PubMed 10853681Petrakis E, Sciacca V. Prospective study of transcutaneous oxygen tension (TcPO2) measurement in the testing period of spinal cord stimulation in diabetic patients with critical lower limb ischaemia. Int Angiol. 2000 Mar;19(1):18-25.
- Background: PubMed 33549777Chapman KB, Kloosterman J, Schor JA, Girardi GE, van Helmond N, Yousef TA. Objective Improvements in Peripheral Arterial Disease from Dorsal Root Ganglion Stimulation: A Case Series. Ann Vasc Surg. 2021 Jul;74:519.e7-519.e16. doi: 10.1016/j.avsg.2021.01.069. Epub 2021 Feb 4.
- Background: PubMed 24712687De Caridi G, Massara M, David A, Giardina M, La Spada M, Stilo F, Spinelli F, Grande R, Butrico L, de Franciscis S, Serra R. Spinal cord stimulation to achieve wound healing in a primary lower limb critical ischaemia referral centre. Int Wound J. 2016 Apr;13(2):220-5. doi: 10.1111/iwj.12272. Epub 2014 Apr 8.
- Background: PubMed 35466931Cucuruz B, Kopp R, Hampe-Hecht H, Andercou O, Schierling W, Pfister K, Koller M, Noppeney T. Treatment of end-stage peripheral artery disease by neuromodulation. Clin Hemorheol Microcirc. 2022;81(4):315-324. doi: 10.3233/CH-221436.
- Background: PubMed 33550918Cyrek AE, Henn N, Meinhardt F, Lainka M, Pacha A, Paul A, Koch D. Improving Limb Salvage for Chronic Limb-Threatening Ischemia With Spinal Cord Stimulation: A Retrospective Analysis. Vasc Endovascular Surg. 2021 May;55(4):367-373. doi: 10.1177/1538574420985765. Epub 2021 Feb 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Pellegrino, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation in people with Peripheral Arterial Disease and Painful Diabetic Neuropathy, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia T Hoffman, MSN (402-552-3077, outcomesresearch@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-frequency Spinal Cord Stimulation Effect on Analgesia (time frame: Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480786, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.