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Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain

NCT00458497 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-06-04

No results posted yet for this study

Summary

This study is designed to assess the effects of socks and bedding materials on foot pain, the level of blood oxygen existing in the feet and quality of sleep in subjects who have chronic foot pain from either diabetic neuropathy or other conditions, e.g., peripheral arterial disease, regenerative joint disease). The three main hypotheses to be tested are: 1)compared to placebo socks, subjects wearing Holofiber socks experience reduction in foot pain, 2)compared to placebo bedding, subjects sleeping in beds lined with a Holofiber mattress pad experience improved quality of sleep and 3) compared to placebo socks, subjects who wear Holofiber socks will have increased blood oxygenation levels in their feet.

Conditions

  • Diabetic Neuropathy
  • Arthritis
  • Peripheral Arterial Disease
  • Plantar Fasciitis

Interventions

DEVICE

Holofiber fabric

Subjects will be given 3 pairs of socks (subjects with foot pain only) and bedding (mattress pad)fabricated from 1.8 dernier polyethylene terephthalate (PET) fabric to which Holofiber particles have been added during fiber manufacture.

DEVICE

PET fabric

Subjects will be given 3 pairs of socks (subjects with foot pain only) and bedding (mattress pad)fabricated from 1.8 dernier polyethylene terephthalate (PET)fabric.

Sponsors & Collaborators

  • Hologenix, LLC

    collaborator INDUSTRY

  • Southern California Institute for Research and Education

    lead OTHER

Principal Investigators

  • Ian Gordon, M.D., Ph.D. · VA Long Beach Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT00458497 on ClinicalTrials.gov