NCT01175928

Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

Phase 2 Study of the NormaTec PCD in the Treatment of Diabetic Peripheral Neuropathy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: NormaTec Industries LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DEVICE	Sham device	Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
DEVICE	NormaTec PCD (Peristaltic Pulse PCD)	Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-08-05
• Last updated: 2012-04-20

Locations

1 site across 1 country: United States