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Not Yet Recruiting
NCT07696988
PNS to Improve Vascular Function and Limb Health in Veterans
Conditions: Lower Limb Amputees, Diabetes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 42
Sponsor: VA Office of Research and Development
Location: Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio
Summary
Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07696988). StuddyBuddy aggregates publicly available trial information.