NCT05577390Recruiting
A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
Diabetic peripheral neuropathy is one of the most common and costly microvascular complications of diabetes impacting more than 50% of patients and costing more than 10.1 billion dollars annually. Intraneural Facilitation Therapy (INF® Therapy) is a non-invasive technique that has shown to improve balance and pain in patients with Type 2 Diabetic Peripheral Neuropathy (T2DPN); however, the underlying physiological mechanisms need further understanding. The purpose of this study is to investigate the physiological mechanisms behind two approaches to treating T2DPN, INF® Therapy and standard physical therapy. Eligible subjects presenting with diabetic neuropathy symptoms will be recruited and referred to the Loma Linda University Health's Neuropathic Therapy Center. Forty patients will be evenly randomized into two groups: an INF® Therapy Treatment group and standard physical therapy treatment group. Subjects will participate in 11 study visits over a period of 6 weeks. Non-invasive assessments will measure neuropathy pain, heart rate variability, neuropathy severity, blood oxygen levels, and blood flow under the skin. Lab draws will measure inflammation levels in the blood and how well blood sugar levels have been maintained over a period of about 3 months. Descriptive statistics and repeated measures ANOVA will be used to analyze data and answer the research questions. The findings of this study will provide a better understanding of how INF® Therapy and standard physical therapy work, subsequently improving non-invasive treatment methods for T2DPN patients.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 Sept 2022
- Start date
- 8 Jan 2024
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Loma Linda University
- Diseases
- Type 2 diabetes
- NCT number
- NCT05577390
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 8 Jan 2024 to the primary completion date, 1 Aug 2027
- 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
- Chemotherapy
- Radiation
- Documented active drug and or alcohol misuse
Other illness
- Subjects with a medical condition predisposing them to medical decline during the next 6 months will be excluded from the study. Examples include:
- Chronic liver disease
- Other types of neuropathies not associated with diabetes including B12 deficiency and Charcot Marie Tooth
- Allergies to cobalt, chrome, or nickel
Other
- Lower extremity amputations
- Open wounds
- Active inflammations
- Morbid obesity
- Pregnancy.
- Taking beta blockers
- Unable to maintain steady fingers or operate a cellphone
- Smoking or ingesting marijuana
- Having a pacemaker
Who the study is looking for
- Between the ages of 45 and 85
- Moderate to severe type II diabetic neuropathy with one or more symptoms including: numbness, tingling, burning, sharp pain, and/or increased sensitivity.
- Diagnosis confirmed by a physician.
- Cellphone access with Android 5.0 and up or iOS 14.0 or later.
Age in the registry: 45 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Loma Linda University Health Neuropathic Therapy Center Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.