PNS to Improve Vascular Function and Limb Health in Veterans
Starting soon · Not applicable · Has a placebo group
Conditions studied: Lower Limb Amputees, Diabetes
In brief
Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.
Key facts
- Study ID
- NCT07696988
- Run by
- VA Office of Research and Development
- People needed
- 42
- Starts
- 2026-11-02
- Expected to finish
- 2030-05-30
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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