The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
Completed · Not applicable · Has a placebo group
Conditions studied: Diabetic Neuropathy
In brief
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 - severe below ankle neuropathy symptoms. Since INF has shown success in the clinic and significant improvements have been found in a recent pilot study, this study aims to further explore these effects on DMT2 subjects suffering from DPN. The investigators would like to investigate if INF improves blood flow in the foot, if it decreases the pain and improves the sensation, and if it improves the overall quality of life.
Key facts
- Study ID
- NCT04025320
- Run by
- Loma Linda University
- People needed
- 30
- Starts
- 2019-09-27
- Expected to finish
- 2020-12-10
- Last updated by the study team
- 2021-05-17
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Loma Linda University — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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