Diabete Type 2CDINNCT07213843
Combined Circulatory and Dietary Interventions for Neuropathy
A study testing INF® Therapy and NVIf in people with Diabete Type 2 and Neuropathy, Painful, run by Loma Linda University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Diabete Type 2, Neuropathy, Painful
- What is being tested?
- INF® Therapy and NVIf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Neuropathic Therapy Center
Loma Linda, California, 92354-0200
Mark Bussell, DPT, 909-558-6799, mbussell@llu.edu
Kyan Z Sahba, PhD, 7142350087, kyansahba@llu.edu
About this study
Official title: Combined Circulatory and Dietary Interventions for Neuropathy (CDIN)
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 detailed 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.
- Conditions
- Diabete Type 2, Neuropathy, Painful
- Being tested
- INF® Therapy, NVIf
- Keywords
- neuropathy, diabetes type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Neuropathy, Painful
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INF® TherapyOther
Also called Intranerual Facilitation
INF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner,
NVIfOther
Also called Neuro vascular index food-guided elimination
NVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens
| Study group | Role | What they receive |
|---|---|---|
| INF® Therapy Only Group | Experimental | 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. Receives: Other: INF® Therapy |
| NVIf Only Group | Experimental | 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. Receives: Other: NVIf |
| INF® Therapy + NVIf Group | Experimental | 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. Receives: Other: INF® Therapy; Other: NVIf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
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.
Measured: Baseline (Week 0) and post-intervention (Week 4-5)
Change in Sensory Function
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)
Measured: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)
Change in Functional Limitation
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).
Measured: Baseline (Week 0) and post-intervention (Week 4-5)
Change in Gait Speed
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)
Measured: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)
Change in Mobility and Fall Risk
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.
Measured: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)
Secondary outcomes (1)
Change in Quality of Life
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.
Measured: Baseline (Week 0) and post-intervention (Week 4-5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel assignment study with three active treatment arms (INF® therapy only, NVIf only, and INF® + NVIf) to compare their effects on neuropathy symptoms
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyan Sahba, Loma Linda University
- Investigators
- Kyan Sahba, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213843
- Sponsor's protocol ID
- 5250381
- Acronym
- CDIN
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD). De-identified aggregate data may be made available upon reasonable request to the Principal Investigator, following study completion and publication of primary results, in accordance with institutional policies and IRB approval.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Circulatory and Dietary Interventions for Neuropathy (CDIN)
- ClinicalTrials.gov ID
- NCT07213843
- Acronym / sponsor ID
- CDIN / 5250381
- Conditions
- Diabete Type 2, Neuropathy, Painful
- Keywords
- neuropathy, diabetes type 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized, parallel assignment study with three active treatment arms (INF® therapy only, NVIf only, and INF® + NVIf) to compare their effects on neuropathy symptoms
| Arm | Type | Receives |
|---|---|---|
| INF® Therapy Only Group | Experimental | Other: INF® TherapyINF® 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. |
| NVIf Only Group | Experimental | Other: NVIfNVIf, 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. |
| INF® Therapy + NVIf Group | Experimental | Other: INF® Therapy, Other: NVIfINF® 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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INF® TherapyAlso: Intranerual FacilitationINF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner, | Other | INF® Therapy + NVIf Group, INF® Therapy Only Group |
| NVIfAlso: Neuro vascular index food-guided eliminationNVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens | Other | INF® Therapy + NVIf Group, NVIf Only Group |
Primary outcome
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.
1 secondary outcome
Change in Quality of Life
Time frame: Baseline (Week 0) and post-intervention (Week 4-5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- A Retrospective Assessment of Neuropathic Pain in Response to Intraneural Facilitation® Therapy and Neurovascular Index-Guided Food EliminationLink provided by the sponsor.
- Treating peripheral neuropathy in individuals with type 2 diabetes mellitus with intraneural facilitation: a single blind randomized control trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD). De-identified aggregate data may be made available upon reasonable request to the Principal Investigator, following study completion and publication of primary results, in accordance with institutional policies and IRB approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyan Sahba, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INF® Therapy and NVIf in people with Diabete Type 2 and Neuropathy, Painful, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyan Sahba, Post Doctoral Fellow, PhD (9095586799, kyansahba@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline (Week 0) and post-intervention (Week 4-5)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.