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

Primary Purpose

Diabetic Neuropathy, Arthritis, Peripheral Arterial Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Holofiber fabric
PET fabric
Sponsored by
Southern California Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Holofiber, chronic foot pain, sleep quality

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria SUBJECTS WITH DIABETIC NEUROPATHY:

  • Presence of diabetic neuropathic pain with score of 3 or higher on the McGill Short Form Pain Survey
  • Presence of sensory neuropathy with monofilament (Semmes-Weinstein) testing, as defined as failure to sense the filament in 2 locations (out of six total) on a least one foot.
  • Previous diagnosis of diabetes (type II) as well as diabetic neuropathy by a physician
  • Age greater or equal to 21

Exclusion Criteria SUBJECTS WITH DIABETIC NEUROPATHY:

  • Presence of significant peripheral arterial disease in either lower extremity (abi greater than 0.9 bilaterally)
  • Skin ulceration on either foot or limb threat from infection or vascular disease at study enrollment
  • Inability to comply with study procedures or give informed consent
  • Women of child bearing potential
  • Spouse/partner is a women of child bearing potential and you share the same bed
  • Non-ambulatory status
  • Inability to comply with study restrictions on changing sleeping or pain medication
  • Severe psychiatric or medical disorder that would affect compliance
  • Known allergy to PET or Dacron

Inclusion Criteria SUBJECTS WITHOUT DIABETIC NEUROPATHY:

  • Chronic foot or angle pain with a score of 3 or higher on the McGill Short Form Pain Scale
  • Absence of sensory neuropathy with monofilament (Semmes-Weinstein) testing, as defined as ability to sense the filament in 6 locations (out of 6 total) on both feet
  • The presence of a condition that causes chronic foot pain such as arthritis, peripheral arterial disease, plantar fasciitis, or other conditions not related to diabetic neuropathy, previously diagnosed by a health care provider
  • Age greater to or equal to 21

Exclusion Criteria SUBJECTS WITHOUT DIABETIC NEUROPATHY:

  • Presence of significant peripheral arterial disease in either lower extremity (abi less than or equal to 0.5 in either extremity)
  • Skin ulceration on either foot or limb threat from infection or vascular disease at study enrollment
  • Inability to comply with study procedures or give informed consent
  • Women of child bearing potential
  • Spouse/partner is a women of child bearing potential and you share the same bed
  • Non-ambulatory status
  • Inability to comply with study restrictions on changing sleeping or pain medication
  • Severe psychiatric or medical disorder that would affect compliance
  • Previous diagnosis of neuropathy affecting lower extremities
  • Known allergy to PET or Dacron

Sites / Locations

  • VA Long Beach Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Significant differences between the average scores from the two pre-randomization questionnaire sets and the two post-randomization questionnaire sets.
Oxygenation levels of blood in the feet will be compared between Holofiber and placebo socks at several time points using standard nonparametric t-test statistics.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2007
Last Updated
June 2, 2010
Sponsor
Southern California Institute for Research and Education
Collaborators
Hologenix, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00458497
Brief Title
Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain
Official Title
Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Southern California Institute for Research and Education
Collaborators
Hologenix, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Holofiber is a patented process for adding micron sized optically active quartz, aluminum oxide and titanium oxide particles to polymer yarns. It is believed that the Holofiber particles increase skin illumination such that pigments and other enzymes are activated, leading to increased blood flow and oxygenation of the skin and neighboring soft tissues. Previous clinical trials have demonstrated approximately a 7% increase in skin oxygen levels with the use of Holofiber gloves and socks, compared to gloves and socks fabricated from identical polymer fiber lacking the optical particles. Numerous anecdotal reports from patients with chronic foot and arm pain indicate wearing Holofiber garments for even a few days leads to dramatic improvement in many different painful conditions. Similarly, many subjects with chronic sleep disturbances have reported improved quality of sleep using Holofiber bedding. The current study is designed to 1) substantiate the ability of Holofiber socks to alleviate chronic pain resulting from diabetic neuropathy and other chronic foot disorders, 2) determine if Holofiber bedding improves quality of sleep and 3) determine if Holofiber socks increase blood oxygenation levels in the feet after wear. Subjects who give informed consent and meet the study inclusion and exclusion criterial will undergo a brief medical history and physical examination, including monofilament testing for sensory neuropathy and measurement of blood pressure in all four extremities using Doppler ultrasound, and will answer a panel of questionnaires that assess pain and sleep quality. Spouses or partners of eligible subjects will similarly be consented to fill out the questionnaires related to sleep if they share the same bed with the participating subject. Subjects and spouses/partners will be asked to return one week later to complete the same questionnaires, at which time subjects will be randomized (double-blind) to receive either Holofiber or placebo socks and bedding materials. Subjects will be instructed to use the socks and bedding material exclusively for two weeks. Subjects and spouses/partners will return at three and four weeks for follow-up with repeat questionnaires at each visit. At Visit 4, subjects will have their feet photographed using a Hyperspectral camera to identify blood oxygenation before and after wearing the Holofiber and placebo socks. Once the final set of photographs has been taken, the visit is ended and the patients participation is concluded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Arthritis, Peripheral Arterial Disease, Plantar Fasciitis
Keywords
Holofiber, chronic foot pain, sleep quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Holofiber fabric
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PET fabric
Intervention Description
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.
Primary Outcome Measure Information:
Title
Significant differences between the average scores from the two pre-randomization questionnaire sets and the two post-randomization questionnaire sets.
Time Frame
four weeks
Title
Oxygenation levels of blood in the feet will be compared between Holofiber and placebo socks at several time points using standard nonparametric t-test statistics.
Time Frame
Baseline photos of feet without socks; immediately afer baseline photos, Holofiber sock placed on one foot, placebo sock placed on the other foot; second photos with socks one hour later; final photos with socks four hours later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria SUBJECTS WITH DIABETIC NEUROPATHY: Presence of diabetic neuropathic pain with score of 3 or higher on the McGill Short Form Pain Survey Presence of sensory neuropathy with monofilament (Semmes-Weinstein) testing, as defined as failure to sense the filament in 2 locations (out of six total) on a least one foot. Previous diagnosis of diabetes (type II) as well as diabetic neuropathy by a physician Age greater or equal to 21 Exclusion Criteria SUBJECTS WITH DIABETIC NEUROPATHY: Presence of significant peripheral arterial disease in either lower extremity (abi greater than 0.9 bilaterally) Skin ulceration on either foot or limb threat from infection or vascular disease at study enrollment Inability to comply with study procedures or give informed consent Women of child bearing potential Spouse/partner is a women of child bearing potential and you share the same bed Non-ambulatory status Inability to comply with study restrictions on changing sleeping or pain medication Severe psychiatric or medical disorder that would affect compliance Known allergy to PET or Dacron Inclusion Criteria SUBJECTS WITHOUT DIABETIC NEUROPATHY: Chronic foot or angle pain with a score of 3 or higher on the McGill Short Form Pain Scale Absence of sensory neuropathy with monofilament (Semmes-Weinstein) testing, as defined as ability to sense the filament in 6 locations (out of 6 total) on both feet The presence of a condition that causes chronic foot pain such as arthritis, peripheral arterial disease, plantar fasciitis, or other conditions not related to diabetic neuropathy, previously diagnosed by a health care provider Age greater to or equal to 21 Exclusion Criteria SUBJECTS WITHOUT DIABETIC NEUROPATHY: Presence of significant peripheral arterial disease in either lower extremity (abi less than or equal to 0.5 in either extremity) Skin ulceration on either foot or limb threat from infection or vascular disease at study enrollment Inability to comply with study procedures or give informed consent Women of child bearing potential Spouse/partner is a women of child bearing potential and you share the same bed Non-ambulatory status Inability to comply with study restrictions on changing sleeping or pain medication Severe psychiatric or medical disorder that would affect compliance Previous diagnosis of neuropathy affecting lower extremities Known allergy to PET or Dacron
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Gordon, M.D., Ph.D.
Organizational Affiliation
VA Long Beach Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19386127
Citation
York RM, Gordon IL. Effect of optically modified polyethylene terephthalate fiber socks on chronic foot pain. BMC Complement Altern Med. 2009 Apr 22;9:10. doi: 10.1186/1472-6882-9-10.
Results Reference
derived
Links:
URL
http://www.scire-lb.org
Description
Southern California Institute for Research and Education website

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

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