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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05577390
The ClinicalTrials.gov registry entry for NCT05577390 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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