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PNS to Improve Vascular Function and Limb Health in Veterans

Key facts

Who runs it
VA Office of Research and Development
Where
Cleveland, United StatesSee the site
Trial code
Status
Not yet recruiting
People taking part
42 people, planned
Started
2 Nov 2026
Expected to end
30 May 2030
Type of study
Interventional, 2 groups
Treatments tested
  • Chronically Implanted Neural and Muscular Interface
  • Peripheral Nerve Stimulation (PNS)
Record updated
21 August 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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
  • 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

Who cannot take part

  • Severe neurological disorders impairing ambulation
  • Cardiovascular or respiratory conditions posing risk during participation
  • Cognitive or psychiatric conditions compromising informed consent
  • History of photosensitivity or known sensitivity to laser light; Additional Exclusion Criteria - Amputees:
  • Active skin breakdown or infection at residual limb
  • Visual or hearing impairments interfering with study participation
  • Participation in other clinical trials interfering with outcomes
  • Pregnancy
  • Significant phantom or residual limb pain interfering with study procedures
  • Bilateral lower-limb amputation

Where in United States

  • Louis Stokes VA Medical Center, Cleveland, OHCleveland, United StatesContact: Jessica R Jarvela, MS BSNot yet recruiting

About the trial

What the trial wants to find out

Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.

The 2 groups in the trial

  • Implanted Neural and Muscular InterfaceTreatment being tested

    6 lower limb loss participants who have already been chronically implanted with neural and muscular interfaces to allow for direct stimulation

    Treatment: Chronically Implanted Neural and Muscular Interface and Peripheral Nerve Stimulation (PNS)

  • Peripheral nerve stimulationTreatment being tested

    30 able body participants and 12 participants with unilateral lower-limb loss with receive peripheral nerve stimulation

    Treatment: Peripheral Nerve Stimulation (PNS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy
Record updated
21 August 2026