PNS for Vascular Function and Limb Health in Veterans
This study is looking at how a treatment called Peripheral Nerve Stimulation (PNS) can help improve blood flow and overall limb health in Veterans. It's also testing a new way to measure nerve and blood vessel health using an implanted device. You might be able to join if you are a Veteran with diabetes and nerve damage (diabetic peripheral neuropathy) or if you've had a lower limb amputation. The researchers want to see if PNS can improve how well your blood vessels respond and increase blood flow to your skin. This could help prevent skin problems and further limb issues. The study aims to enroll 42 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 42 participants. It will test two types of devices: a Chronically Implanted Neural and Muscular Interface and a Peripheral Nerve Stimulation (PNS) interface.
- What's involved
- You would have visits for about one year, with measurements taken at baseline and then at visits 1-15. These measurements include checking your skin's blood flow, vessel density, and tissue oxygen levels.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for approximately one year, with measurements taken until study completion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PNS to Improve Vascular Function and Limb Health in Veterans
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Hamid Charkhkar, PhD · PRINCIPAL_INVESTIGATOR · Louis Stokes VA Medical Center, Cleveland, OH
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Cutaneous Vascular Conductancebaseline and visits 1-15 until study completion, average 1 year
Autonomic reflex testing including thermal axon reflex and pressure induced vasoconstriction will be applied. The cutaneous blood flow in the lower limb will be measured using laser doppler flowmetry. The flux is divided by mean arterial pressure to calculate cutaneous vascular conductance. This provides a physiologically relevant metric of microvascular control by accounting for systemic pressure fluctuations
- Vessel Densitybaseline and visits 1-15 until study completion, average 1 year
Defined as the percentage of tissue volume occupied by vascular structures. The investigators use photoacoustic imaging of microvascular structure to quantify microvascular structural integrity at distal and proximal skin sites. From the reconstructed volumetric data, the investigators will extract the vessel density
- Tissue Oxygen Saturationbaseline and visits 1-15 until study completion, average 1 year
Tissue oxygen saturation or sO2 will be measured during different conditions of the study such as thermal axon reflex and pressure induced vasoconstriction using reflectance spectroscopy
- Mean Vessel Diameterbaseline and visits 1-15 until study completion, average 1 year
Calculated from the cross-sectional profiles of resolved vessels obtained from the photoacoustic imaging of microvascular structures
- Hemoglobin Oxygenationbaseline and visits 1-15 until study completion, average 1 year
From photoacoustic imaging, hemoglobin oxygenation is derived and compared across different study conditions