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NCT00458497 · ClinicalTrials.gov registry record · NA
Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain
A NA study, sponsored by Southern California Institute for Research and Education.
- Terminated
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT00458497: Clinical Trial NA study, sponsored by Southern California Institute for Research and Education.
NCT00458497 is a NA study that was terminated before completion, run by Southern California Institute for Research and Education. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458497, a NA study, was terminated before completion, sponsored by Southern California Institute for Research and Education.
- TERMINATED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
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.
Interventions
- DEVICE Holofiber fabric
- DEVICE PET fabric
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-12 |
| Phase | NA |
Why NCT00458497 stopped before completion
NCT00458497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Holofiber fabric is the first listed.
NCT00458497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00458497 about?
NCT00458497 is a clinical study titled "Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain". 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 jo...
What is the current status of trial NCT00458497?
This trial is currently terminated. It is a NA study. The enrollment target is 60 participants. The study started on 2007-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00458497?
The interventions under investigation include: Holofiber fabric (DEVICE), PET fabric (DEVICE).
Who is sponsoring clinical trial NCT00458497?
This trial is sponsored by Southern California Institute for Research and Education, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00458497's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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