Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain
Diabetic Neuropathy, Arthritis, Peripheral Arterial Disease
About this trial
This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Holofiber, chronic foot pain, sleep quality
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
Sites / Locations
- VA Long Beach Healthcare System
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
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.