Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07696988). StuddyBuddy aggregates publicly available trial information.