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New study tests diet and massage combo for diabetic nerve pain

NCT ID NCT07213843

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test three approaches to reduce painful nerve damage in people with type 2 diabetes. Sixty adults aged 35-85 with moderate to severe neuropathy will receive either a special massage-like therapy (INF), a diet guided by a food sensitivity test (NVIf), or both together. The goal is to see which combination best improves pain, walking, and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Neuropathic Therapy Center

    Loma Linda, California, 92354-0200, United States

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