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New treatment option for Peripheral Arterial Disease
Official title SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
ClinicalTrials.gov ID: NCT06480786
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 89
You may be able to join if
- 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...
- Successful spinal cord stimulator (SCS) trial (\>50% relief of chronic lower extremity pain) and will have a new permanent SCS placed prior to study...
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.