PNS to Improve Vascular Function and Limb Health in Veterans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chronically Implanted Neural and Muscular Interface, Peripheral Nerve Stimulation (PNS).
- Who it may be relevant to
- Registry conditions: Lower Limb Amputees, Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy
Overview
Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.
Detailed description
The overarching goal of this project is to define how targeted afferent activation can be used to restore impaired neurovascular reflexes, improve skin perfusion, and ultimately prevent further decline in limb health in Veterans. By integrating functional and structural imaging with neural modulation, this work will establish foundational evidence for diagnostic and therapeutic strategies aimed at early detection of neurovascular decline and prevention of tissue breakdown in both Diabetic Peripheral Neuropathy (DPN) and residual-limb contexts. Furthermore, this work will establish the feasibility of preventing or delaying the mechanical trauma of the insensate distal limb which invariably leads to deep pressure injuries, infections, and amputation in Veterans with DPN. The findings have the potential to transform care by enabling earlier diagnosis, improving neurovascular responsiveness, and optimizing neuromodulation protocols to prevent skin complications, delay progression toward amputation, and improve quality of life in Veterans with DPN or limb loss.
Interventions
- Device Chronically Implanted Neural and Muscular Interface
The implanted neural and and muscular interface will be used to characterize neurovascular reflex testing (thermal axon reflex \& pressure-induced vasodilation) and microvascular imaging using Laser Doppler Flowmetry and PAI. Reflex responses will be evaluated under baseline and stimulation conditions (sham, tonic, biomimetic), with direct stimulation performed by the CFINE cohort for modality comparison. Structural-functional relationships will be modeled by integrating metrics from PAI with re - Device Peripheral Nerve Stimulation (PNS)
The cutaneous peripheral nerve stimulation interface will be used to characterize neurovascular reflex testing (thermal axon reflex \& pressure-induced vasodilation) and microvascular imaging using Laser Doppler Flowmetry and PAI. Reflex responses will be evaluated under baseline and stimulation conditions (sham, tonic, biomimetic). Structural-functional relationships will be modeled by integrating metrics from PAI with reflex outcomes.
Primary outcome measures
- Cutaneous Vascular Conductance [Time frame: baseline and visits 1-15 until study completion, average 1 year]
- Vessel Density [Time frame: baseline and visits 1-15 until study completion, average 1 year]
- Tissue Oxygen Saturation [Time frame: baseline and visits 1-15 until study completion, average 1 year]
- Mean Vessel Diameter [Time frame: baseline and visits 1-15 until study completion, average 1 year]
- Hemoglobin Oxygenation [Time frame: baseline and visits 1-15 until study completion, average 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
Identifiers
NCT: NCT07696988 · RRD5-006-25W · RD001968-01 · 1584038