Diabetic NeuropathyNCT00458497
Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain
A study testing Holofiber fabric and PET fabric in people with Diabetic Neuropathy and Arthritis, run by Southern California Institute for Research and Education at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetic Neuropathy, Arthritis, Peripheral Arterial Disease
- What is being tested?
- Holofiber fabric and PET fabric
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Long Beach Healthcare System
Long Beach, California, 90822
About this study
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.
Read the 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.
- Being tested
- Holofiber fabric, PET fabric
- Keywords
- Holofiber, chronic foot pain, sleep quality
- Medical subject headings
- Diabetic Neuropathies, Arthritis, Peripheral Arterial Disease, Fasciitis, Plantar, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holofiber fabricDevice
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.
PET fabricDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Device: Holofiber fabric |
| 2 | Placebo comparator | 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. Receives: Device: PET fabric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant differences between the average scores from the two pre-randomization questionnaire sets and the two post-randomization questionnaire sets.
Measured: four weeks
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Hologenix, LLC
- Investigators
- Ian Gordon, M.D., Ph.D., Principal investigator, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458497
- Sponsor's protocol ID
- #788
- Status last verified
- Jun 2010
- First submitted
- 9 Apr 2007
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19386127
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain
- ClinicalTrials.gov ID
- NCT00458497
- Acronym / sponsor ID
- #788
- Keywords
- Holofiber, chronic foot pain, sleep quality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Hologenix, LLC
- Study start
- Apr 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Holofiber fabricSubjects 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. |
| 2 | Placebo comparator | Device: PET fabricSubjects 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Chronic foot or angle pain with a score of 3 or higher on the McGill Short Form Pain Scale
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holofiber fabricSubjects 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 | 1 |
| PET fabricSubjects 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. | Device | 2 |
Primary outcome
Significant differences between the average scores from the two pre-randomization questionnaire sets and the two post-randomization questionnaire sets.
Time frame: four weeks
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
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
- Derived from this study: PubMed 19386127York 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.
- Southern California Institute for Research and Education websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Gordon, M.D., Ph.D. principal investigator
VA Long Beach Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holofiber fabric and PET fabric in people with Diabetic Neuropathy and Arthritis, run by Southern California Institute for Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant differences between the average scores from the two pre-randomization questionnaire sets and the two post-randomization questionnaire sets. (time frame: four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00458497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.