PNS to Improve Vascular Function and Limb Health in Veterans (NCT07696988) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PNS to Improve Vascular Function and Limb Health in Veterans
United States42 participantsStarted 2026-11-02
Plain-language summary
Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion Criteria - All Participants:
* English-speaking
Inclusion Criteria - DPN Participants:
* Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 5 years
* Clinical signs and/or symptoms consistent with diabetic peripheral neuropathy Or confirmation of neuropathy via physical exam
Inclusion Criteria - Lower Limb Amputees:
* Unilateral transtibial or transfemoral amputation
* Medically stable for at least 3 months
* For the designated subset of the limb-loss cohort (n = 6): implanted with C-FINEs on the sciatic and/or tibial nerves
Exclusion Criteria:
Exclusion Criteria - All Participants:
* Severe neurological disorders impairing ambulation
* Visual or hearing impairments interfering with study participation
* Cardiovascular or respiratory conditions posing risk during participation
* Cognitive or psychiatric conditions compromising informed consent
* Participation in other clinical trials interfering with outcomes
* Pregnancy
* History of photosensitivity or known sensitivity to laser light
Additional Exclusion Criteria - Amputees:
* Active skin breakdown or infection at residual limb
* Significant phantom or residual limb pain interfering with study procedures
* Bilateral lower-limb amputation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cutaneous Vascular Conductance
Timeframe: baseline and visits 1-15 until study completion, average 1 year
2
Vessel Density
Timeframe: baseline and visits 1-15 until study completion, average 1 year
3
Tissue Oxygen Saturation
Timeframe: baseline and visits 1-15 until study completion, average 1 year
4
Mean Vessel Diameter
Timeframe: baseline and visits 1-15 until study completion, average 1 year
5
Hemoglobin Oxygenation
Timeframe: baseline and visits 1-15 until study completion, average 1 year