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Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

NCT01175928 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-04-20

No results posted yet for this study

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.

Conditions

  • Diabetic Polyneuropathy

Interventions

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • NormaTec Industries LP

    lead INDUSTRY

Principal Investigators

  • Nicholas Spirito, MD · Saints Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01175928 on ClinicalTrials.gov