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Combined Circulatory and Dietary Interventions for Neuropathy

This study is looking at new ways to help people aged 35-85 with painful type 2 diabetes neuropathy (nerve damage that causes pain, numbness, or tingling). It's testing three different approaches: INF® Therapy (a manual technique to improve blood flow to nerves), NVIf (a diet based on how your blood vessels react to certain foods), or a combination of both. The goal is to see which treatment best improves your pain, sensation, and ability to do daily activities. You can join if a doctor has confirmed you have peripheral neuropathy in your lower legs and you have moderate to significant difficulty with leg function. The study aims to enroll 60 participants, but its current recruitment status is unclear.

Study design
This interventional study will randomly assign 60 participants to one of three treatment groups: INF® Therapy alone, NVIf alone, or both combined.
What's involved
You would participate in intervention and follow-up visits. Your pain, sensory function, and ability to move will be measured at the start, during, and after treatment (around 4-5 weeks).
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored at the start of the study, mid-treatment (Week 3), and post-intervention (Week 4-5).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07213843

Combined Circulatory and Dietary Interventions for Neuropathy

Not Yet Recruiting
NAAges 35–85InterventionalTreatment
Loma Linda University
~60 participants
Updated 2025-10-09 on ClinicalTrials.gov
What's tested:INF® TherapyNVIf

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain Intensity
Measured over Baseline (Week 0) and post-intervention (Week 4-5)
+4 more outcomes measured

Conditions

Diabete Type 2
Neuropathy, Painful

Explore related trials

Peripheral NeuropathyType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Kyan Sahba, PhD · PRINCIPAL_INVESTIGATOR · Loma Linda University

Who to contact

Kyan Sahba, Post Doctoral Fellow, PhD
[email protected]
9095586799
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in Pain IntensityBaseline (Week 0) and post-intervention (Week 4-5)

    Pain intensity will be assessed using the Visual Analog Scale. Improvement will be indicated by reduced VAS scores. Unit of Measure: Millimeters on a 0-100 mm scale.

  • Change in Sensory FunctionBaseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)

    Sensory function will be assessed using the Semmes-Weinstein Monofilament test. Improvement will be indicated by increased monofilament detection. Detection threshold in grams (monofilament response: detected/not detected)

  • Change in Functional LimitationBaseline (Week 0) and post-intervention (Week 4-5)

    Functional limitation related to neuropathy will be assessed using the Lower Extremity Functional Scale. Improvement will be indicated by higher Lower Extremity Functional Scale scores. Scale score (0-80).

  • Change in Gait SpeedBaseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)

    Gait speed will be assessed using the 10-Meter Walk Test. Improvement will be indicated by faster walk time. Seconds to complete 10 meters (converted to meters/second if applicable)

  • Change in Mobility and Fall RiskBaseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)

    Mobility and fall risk will be assessed using the Timed Up and Go (TUG) test. Improvement will be indicated by shorter completion times. Unit of Measure: Seconds.