Diabetic Polyneuropathy Clinical Trial
Official title:
Phase 2 Study of the NormaTec PCD in the Treatment of Diabetic Peripheral Neuropathy
The purpose of this study is to evaluate the efficacy of the NormaTec PCD, a non-invasive
pneumatic compression device with the patented peristaltic pulse pneumatic waveform, in the
treatment of Diabetic Peripheral Neuropathy (DPN).
The study will compare treatment with a NormaTec PCD and a sham device to assess whether the
NormaTec PCD improves the signs and symptoms of DPN.
Diabetes frequently leads to decreased sensation in the legs caused by diabetic peripheral
neuropathy (DPN). DPN is an important risk factor for the development of foot ulceration,
one of the most common causes for hospital admissions and lower-limb amputations among
diabetic patients. However, to date there are no medications currently approved by the Food
and Drug Administration to treat DPN.
The goal of this research project is to assess the effectiveness of a non-invasive, patented
peristaltic pulse pneumatic compression device (the NormaTec PCD) in a home treatment
program to improve the symptoms of DPN (e.g. numbness, pain, and tingling in the legs) and
the underlying functioning of the nerves in the legs (as determined by sensory perception
assessments and Nerve Conduction Studies testing).
In this prospective, randomized, double-blind study, subjects will be randomly placed in one
of two groups: a control group using a sham NormaTec PCD ("placebo"); and an experimental
group using a NormaTec PCD.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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