Combined Circulatory and Dietary Interventions for Neuropathy
Diabete Type 2 · Neuropathy, Painful
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 35 years - 85 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 0 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
Study was never initiated/no study participants were ever enrolled/study was never funded.
About the research
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.
Read the full description
The purpose of this investigator-initiated study is to observe the effectiveness of a manual physical therapy technique known as Intraneural Facilitation (INF®), both independently and in combination with a Nutritional Vascular Inflammation focused (NVIf) dietary intervention, in improving neurovascular function, pain, and physical performance in individuals with moderate to severe peripheral neuropathy (PN). Subjects will be randomized into one of the three interventions arms: (1) INF® therapy alone, (2) NVIf intervention alone or (3) a combination of both. INF® is a manual therapy, while NVIf utilizes ultrasound guided food elimination. Outcomes include pain (Visual analog scale), sensory function (Semmes Weinstein Monofilament), physical function (Lower extremity functional scale, 10-meter walk test, timed up and go) quality of life (Norfolk Quality of life-Diabetic neuropathy), and neurovascular blood flow analysis. Study participants will be 35-85 years old with a physician-confirmed diagnosis of moderate to severe lower extremity peripheral neuropathy and at least one symptom: numbness, tingling, burning, sharp pain, or increased sensitivity. They must score 0-60 on the Lower Extremity Functional Scale (LEFS), speak and understand English, provide written informed consent, and be willing to complete all study procedures, including intervention and follow-up visits. Participants must be able to ambulate independently with or without an assistive device. Subjects will be recruited using email and flyer through the Neuropathic Therapy Center (NTC) research interest list and through providers at Loma Linda's University (LLU) Health offices. 60 subjects will be recruited, and consent will take place at the LLU or at the Murrieta study site prior to randomization, administered by trained study staff authorized to obtain informed consent.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria
- 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 Criteria
- 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
INF® Therapy Only Group
INF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner. Participants will receive 60-minute sessions, 2-3 times per week, for a total of 8 sessions.
Other: INF® Therapy
NVIf Only Group
NVIf, is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens. By identifying foods that exacerbate inflammation and restrict circulation, the intervention guides patients to eliminate these foods, thereby improving nerve health. Those in this group will participate in follow-up for food elimination adherence, including daily tracking of foods ingested. Week 1-2: 4 x NVI food guided-elimination visits. Week 2-5 complete weekly Likert scale inquiring about food eliminations and weekly phone call check-in attempts will be made by research staff.
Other: NVIf
INF® Therapy + NVIf Group
INF® therapy and NVI Food-Guided Elimination Group: Week 1-2: 4 x NVI food guided-elimination visits. Participants will receive 60-minute sessions, 2-3 times per week, for a total of 8 sessions. As well as participate in NVIf, which is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens. By identifying foods that exacerbate inflammation and restrict circulation, the intervention guides patients to eliminate these foods, thereby improving nerve health. Those in this group will participate in follow-up for food elimination adherence, including daily tracking of foods ingested. Week 2-5 complete weekly Likert scale inquiring about food eliminations and weekly phone call check-in attempts will be made by research staff as well as INF® therapy for 60-minute sessions, 2-3 times per week, for a total of 8 sessions.
Other: INF® Therapy · Other: NVIf
INF® Therapy OTHER
INF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner,
NVIf OTHER
NVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change in Pain Intensity
Time frame: Baseline (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 Function
Time frame: Baseline (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 Limitation
Time frame: Baseline (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 Speed
Time frame: Baseline (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 Risk
Time frame: Baseline (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.
Secondary measures
Change in Quality of Life
Time frame: Baseline (Week 0) and post-intervention (Week 4-5)
Quality of life will be measured using the Norfolk Quality of Life-Diabetic Neuropathy questionnaire to determine the effect of each treatment approach on overall patient well-being. Higher scores indicate greater impairment; a reduction reflects improved quality of life. Lowest score=0, means best quality of life with little to no neuropathy impacts. A maximum score of 138, means worst quality of life with severe impairments.
Other measures
Change in Neurovascular Function and Inflammation
Time frame: Baseline (Week 0) and post-intervention (Week 4-5)
Mechanistic analysis will be performed using the Neurovascular Index with Philips Affinity 50 Ultrasound to evaluate changes in microvascular resistance and neurovascular blood flow, as well as the effect of NVI-guided food elimination on reducing neurovascular inflammation.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Neuropathic Therapy CenterLoma Linda, California, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Loma Linda University
- Study start
- Oct 1, 2026 Estimated
- Primary completion
- Oct 1, 2028 Estimated
- Study completion
- Dec 1, 2028 Estimated
- First posted
- Oct 9, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Combined Circulatory and Dietary Interventions for Neuropathy (CDIN)
Ask Wellness Clinical Research
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026