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New treatment option for Peripheral Neuropathy With Type 2 Diabetes
Official title A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy
ClinicalTrials.gov ID: NCT05577390
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 85
You may be able to join if
- 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...
- Diagnosis confirmed by a physician.
- Cellphone access with Android 5.0 and up or iOS 14.0 or later.
You likely can't join if
- people with a medical condition predisposing them to medical decline during the next 6 months will be excluded from the study. Examples include:
- Chemotherapy
- Radiation
- Lower extremity amputations
- Open wounds
- Documented active drug and or alcohol misuse
See the full eligibility criteria
- 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.
- people with a medical condition predisposing them to medical decline during the next 6 months will be excluded from the study. Examples include:
- Chemotherapy
- Radiation
- Lower extremity amputations
- Open wounds
- Documented active drug and or alcohol misuse
- Chronic liver disease
- Active inflammations
- Other types of neuropathies not associated with diabetes including B12 deficiency and Charcot Marie Tooth
- Morbid obesity
- Pregnancy.
- Taking beta blockers
- Unable to maintain steady fingers or operate a cellphone
- Smoking or ingesting marijuana
- Having a pacemaker
- Allergies to cobalt, chrome, or nickel
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.