Status:

COMPLETED

The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy

Lead Sponsor:

Loma Linda University

Conditions:

Diabetic Neuropathy

Eligibility:

All Genders

50-75 years

Phase:

NA

Brief Summary

The purpose of this graduate student research study is to explore the effects of a new treatment known as Intraneural facilitation (INF) on Diabetes Mellitus Type 2 (DMT2) subjects who have moderate -...

Detailed Description

The demographic data (age, height, gender, and weight) will be collected from each subject. All subjects will go through the following protocol: First, subjects will complete pre-testing measurements ...

Eligibility Criteria

Inclusion

  • Patients with Diabetes Type 2 and Diabetic Peripheral Neuropathy with no other known underlying disease
  • Below ankle Diabetic Peripheral Neuropathy symptoms (numbness, tingling, burning, sharp pain, increased sensitivity, etc.)
  • ≥10 on Quality of Life- Diabetic Neuropathy Scale (QOL- DN)
  • Between age 50-75 years

Exclusion

  • Patients with a medical condition that suggested possible decline in function over the next 6 months such as; a current regimen of chemotherapy, radiation therapy, or dialysis
  • Any lower extremity amputations or wounds
  • Documented active alcohol and/or drug misuse
  • Known health conditions: end stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, advanced chronic obstructive pulmonary disease and active inflammations
  • DM patients with inflammatory neuropathies including chronic inflammatory demyelinating polyneuropathy (CIDP), proximal diabetes neuropathy, and autonomic neuropathies
  • Patients with other types of neuropathies not associated with Diabetes Mellitus such as B12 deficiency, hypothyroidism, and uremia
  • Other severe chronic medical condition requiring active treatment
  • Morbidly Obese patients
  • Pregnancy (self reported)

Key Trial Info

Start Date :

September 27 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 10 2020

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04025320

Start Date

September 27 2019

End Date

December 10 2020

Last Update

May 17 2021

Active Locations (1)

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Loma Linda University

Loma Linda, California, United States, 92350