Combined Circulatory and Dietary Interventions for Neuropathy

Starting soon · Not applicable

Conditions studied: Diabete Type 2, Neuropathy, Painful

In brief

The purpose of this study is to evaluate the effectiveness of three different interventions in improving neuropathy symptoms in individuals aged 35-85 with moderate to severe neuropathy. The study will compare three treatment groups: Intraneural Facilitation® (INF®) therapy alone, INF® therapy combined with Neuro vascular index (NVI) food-guided elimination (NVIf), and NVIf alone. The aim is to determine which treatment results in the greatest improvement in neuropathy symptoms, including quality of life, sensory and pain improvements, and functional outcomes.

Key facts

Study ID

NCT07213843

Run by

Loma Linda University

People needed

60

Starts

2026-10-01

Expected to finish

2028-12-01

Last updated by the study team

2025-10-09

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of peripheral neuropathy in the lower extremities by a physician
• Lower Extremity Functional Scale (LEFS) score between 0-60 (indicating moderate to significant difficulty in lower extremity function)
• Ability to speak and understand English
• Ability to provide appropriate written informed consent
• Willingness to participate in all study procedures, including the intervention and follow-up visits
• Ability to ambulate independently with or without an assistive device

You may not qualify if…

• Any medical condition suggesting potential decline in function over the next 6 months (e.g., ongoing chemotherapy, radiation therapy, or dialysis)
• Active alcohol or drug misuse
• End-stage renal failure
• Uncontrolled hypertension
• Severe dyslipidemia
• Chronic liver disease
• Autoimmune disease
• Advanced chronic obstructive pulmonary disease (COPD)
• Active inflammation
• Shingles-related neuropathy
• Presence of any lower extremity amputations or significant wounds
• Severe chronic medical conditions requiring active treatment that could interfere with study outcomes
• Morbid obesity
• Concomitant use of medications or devices that may interfere with study results or are not allowed per protocol
• Inability to comprehend or provide informed consent
• Inability to speak or understand English
• Pregnancy, breastfeeding, or planning pregnancy during the study period (female participants)
• Inability or unwillingness to adhere to study procedures, including dietary guidelines or follow-up visits
• Inability to complete all required study assessments, including follow-up appointments and questionnaires

Where it is running

• Neuropathic Therapy Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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