Status:
NOT_YET_RECRUITING
Combined Circulatory and Dietary Interventions for Neuropathy
Lead Sponsor:
Loma Linda University
Conditions:
Diabete Type 2
Neuropathy, Painful
Eligibility:
All Genders
35-85 years
Phase:
NA
Brief 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. The study wil...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07213843
Start Date
October 1 2026
End Date
December 1 2028
Last Update
October 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Neuropathic Therapy Center
Loma Linda, California, United States, 92354-0200