PNS to Improve Vascular Function and Limb Health in Veterans
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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
Qualifiers
English-speaking
Veteran
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Chronically Implanted Neural and Muscular Interface
- Peripheral Nerve Stimulation (PNS)
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
VA Office of Research and Development
Lead sponsor
Case Western Reserve University
Collaborator
Source ClinicalTrials.gov