Comparing two methods for treating diabetic peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the physiological mechanisms behind two treatment approaches for diabetic peripheral neuropathy in patients with Type 2 diabetes: Intraneural Facilitation Therapy (INF® Therapy) and standard physical therapy. Eligible participants aged 45 to 85 with moderate to severe neuropathy symptoms will be recruited and randomly assigned to one of the two treatment groups. Over six weeks, participants will undergo a series of assessments including pain quality, neuropathy scales, heart rate variability measurements, and blood tests to evaluate treatment effects. The study aims to enhance understanding of how these therapies work and their impact on patients' symptoms.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

Subjects 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

Where it's running

• Loma Linda University Health Neuropathic Therapy Center
  Loma Linda, California, United States Recruiting

Study contacts

• Principal investigator: Mark Bussell, DPT, OCS — Loma Linda University Health
• Study coordinator: Mark Bussell, DPT, OCS
• Email: ntcresearch@llu.edu
• Phone: 909-558-6799

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Wearable sensory prosthesis to improve coordination, walking, and activity

  This study tests whether the Walkasins sensory device helps adults with peripheral neuropathy walk more and move more, by wearing the device daily for about 10 weeks.

  Recruiting RxFunction Inc. · Jacksonville, Florida · NCT07554443

• Diet to reduce pain from diabetic peripheral neuropathy

  This compares a whole-food, plant-based, no-added-oil diet with usual medications to see if it lowers pain and improves nerve symptoms in adults with painful diabetic neuropathy.

  Recruiting AdventHealth · Hendersonville, North Carolina · NCT07509671

• Walkasins to improve balance for people with peripheral neuropathy

  This project will test whether daily use of Walkasins helps people with peripheral neuropathy improve foot-placement awareness and balance over six months.

  Recruiting at 4 sites RxFunction Inc. · Mesa, Arizona and 5 other locations · NCT06959277

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.