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

NCT00458497 | Terminated

• 1 other identifier: #788
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy; Arthritis; Peripheral Arterial Disease; Plantar Fasciitis

Keywords

Holofiber; chronic foot pain; sleep quality

Outcome Measures

Primary Outcomes (2)

• Significant differences between the average scores from the two pre-randomization questionnaire sets and the two post-randomization questionnaire sets.

  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.

  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

Study Arms (2)

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.

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.

Device: PET fabric

Interventions

Holofiber fabric DEVICE

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.

1

PET fabric DEVICE

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.

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead
• Hologenix, LLC: collaborator

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Related Publications (1)

• 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.

  PMID: 19386127 DERIVED

Related Links

• Southern California Institute for Research and Education website

MeSH Terms

Conditions

Diabetic Neuropathies; Arthritis; Peripheral Arterial Disease; Fasciitis, Plantar; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Joint Diseases; Musculoskeletal Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Fasciitis; Foot Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Ian Gordon, M.D., Ph.D.

  VA Long Beach Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 4, 2010

Record last verified: 2010-06

Locations

US (1)