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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
United States
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Contact Information
Primary
Julia T Hoffman, MSN
outcomesresearch@unmc.edu
402-552-3077
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2027-07
Participants
Target number of participants: 15
Treatments
Experimental: Active Spinal Cord Stimulation
Therapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice.
Sham_comparator: Sham Stimulation
Sub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control.
Sponsors
Leads: University of Nebraska
Collaborators: Nevro Corp

This content was sourced from clinicaltrials.gov

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