Status:
TERMINATED
Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain
Lead Sponsor:
Southern California Institute for Research and Education
Collaborating Sponsors:
Hologenix, LLC
Conditions:
Diabetic Neuropathy
Arthritis
Eligibility:
All Genders
21+ years
Phase:
NA
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 fro...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00458497
Start Date
April 1 2007
End Date
December 1 2009
Last Update
June 4 2010
Active Locations (1)
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1
VA Long Beach Healthcare System
Long Beach, California, United States, 90822