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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
NormaTec
Newton Center, Massachusetts, United States
Nerve Conduction Studies
Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
Time frame: 3 months
Nerve Conduction Studies
Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
Time frame: 1 month
Nerve Conduction Studies
Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
Time frame: 2 months
Sensory perception measurements
Non-invasive sensory perception will be assessed with a 10-g monofilament (pressure); a 128 Hz tuning fork and a Neurothesiometer (vibration); a toothpick (sharp sensation); a cotton ball (soft sensation); an iced tuning fork (cold sensation); and calculation of the Neuropathy Disability Score.
Time frame: baseline; 1 month; 2 months; 3 months
Quality of life questionnaires
The following questionnaires will be self-administered: Norfolk Quality-of-Life Questionnaire for Diabetic Neuropathy (QOL-DN); Neuropathy Total Symptom Score-6 (NTSS-6); Problem Areas in Diabetes (PAID)
Time frame: baseline; 1 month; 2 months; 3 months
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