PNS to Improve Vascular Function and Limb Health in Veterans

Официальное название

Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

• Cutaneous Vascular Conductance [Срок оценки: baseline and visits 1-15 until study completion, average 1 year]
• Vessel Density [Срок оценки: baseline and visits 1-15 until study completion, average 1 year]
• Tissue Oxygen Saturation [Срок оценки: baseline and visits 1-15 until study completion, average 1 year]
• Mean Vessel Diameter [Срок оценки: baseline and visits 1-15 until study completion, average 1 year]
• Hemoglobin Oxygenation [Срок оценки: baseline and visits 1-15 until study completion, average 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland

Идентификаторы

NCT: NCT07696988 · RRD5-006-25W · RD001968-01 · 1584038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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