NCT07213843Not yet recruiting
Combined Circulatory and Dietary Interventions for Neuropathy
Combined Circulatory and Dietary Interventions for Neuropathy (CDIN)
Source: ClinicalTrials.gov · Last updated 9 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Sept 2025
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Loma Linda University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07213843
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Oct 2026 to the primary completion date, 1 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active alcohol or drug misuse
- Concomitant use of medications or devices that may interfere with study results or are not allowed per protocol
Other illness
- Any medical condition suggesting potential decline in function over the next 6 months (e.g., ongoing chemotherapy, radiation therapy, or dialysis)
- End-stage renal failure
- Uncontrolled hypertension
- Chronic liver disease
- Autoimmune disease
- Advanced chronic obstructive pulmonary disease (COPD)
- Severe chronic medical conditions requiring active treatment that could interfere with study outcomes
Other
- Severe dyslipidemia
- Active inflammation
- Shingles-related neuropathy
- Presence of any lower extremity amputations or significant wounds
- Morbid obesity
- 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
Who the study is looking for
- 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
Age in the registry: 35 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neuropathic Therapy Center Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.