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NCT05577390 · ClinicalTrials.gov registry record · NA
A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy
A NA study of Peripheral Neuropathy With Type 2 Diabetes, sponsored by Loma Linda University.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05577390: Recruiting NA study of Peripheral Neuropathy With Type 2 Diabetes, sponsored by Loma Linda University.
NCT05577390 is a NA study of Peripheral Neuropathy With Type 2 Diabetes that is actively recruiting participants, run by Loma Linda University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05577390, a NA study of Peripheral Neuropathy With Type 2 Diabetes, is actively recruiting participants, sponsored by Loma Linda University.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
This is a composite measurement combining electrocardiogram and Welltory App measurements. Heart rate variability (HRV) is the variation in the time interval between consecutive heartbeats and can be used to assess the current state of the nervous system. HRV measures will include LF, HF, LF/HF ratio, SDNN, SDANN, RMSSD, and NN50. The calculation of these variables allows HRV to be quantified. A normal result is between 25 to 50 milliseconds while an abnormal result is less than or greater than
Conditions Studied
Interventions
- OTHER Intraneural Facilitation Therapy Treatment
- OTHER Standard Physical Therapy Treatment
Study Locations (1)
California
- Loma Linda University Health Neuropathic Therapy Center - Loma Linda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-01-08 |
| Est. Completion | 2027-08-01 |
| Phase | NA |
What NCT05577390 shows while recruiting
NCT05577390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Peripheral Neuropathy With Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Intraneural Facilitation Therapy Treatment is the first listed.
NCT05577390 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05577390 about?
NCT05577390 is a clinical study titled "A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy". 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 b...
What is the current status of trial NCT05577390?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-01-08. Estimated completion is 2027-08-01.
What conditions does trial NCT05577390 study?
This clinical trial studies the following conditions: Peripheral Neuropathy With Type 2 Diabetes.
What interventions are being tested in trial NCT05577390?
The interventions under investigation include: Intraneural Facilitation Therapy Treatment (OTHER), Standard Physical Therapy Treatment (OTHER).
Who is sponsoring clinical trial NCT05577390?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05577390 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05577390's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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