Differential Characteristics of Neuropathy in Type 2 Diabetics With and Without Lower Extremity Wounds

Description

The primary purpose of this study is to determine the degree of loss of epidermal nerve fibers near a foot wound in patients with diabetic foot ulcers. The secondary purpose will be to determine whether the degree of epidermal nerve fiber loss, the clinical examination, nerve conduction studies or the molecular profile correlates with appearance of lower extremity ulcers in patients with diabetes.

Study Start Date

December 2014

Estimated Completion Date

December 2017

Interventions

  • Procedure: Diabetic Foot Ulcer Biopsy
  • Other: Wound Photography
  • Other: Survey
  • Other: Comprehensive Neuropathy Assessment

Specialties

  • Neurology: Neuropathy/Myopathy
  • Endocrinology: Diabetes
  • Physician Assistant: Endocrinology,Neurology

MeSH Terms

  • Diabetes Mellitus, Type 2
  • Peripheral Nervous System Diseases

Study ID

Winthrop University Hospital -- 14024

Status

Unknown

Trial ID

NCT02347709

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

30

Sponsor

Winthrop University Hospital

Inclusion Criteria

  • Age ? 18 years
  • Type 2 Diabetes defined as HgA1c ? 5.9%
  • Must be willing and able to provide written Informed Consent

Exclusion Criteria

  • Active osteomyelitis
  • Gangrene
  • Purulent drainage
  • Any experimental drugs applied topically or taken by mouth within 4 weeks of study entry
  • INR > 2.5

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Winthrop University Hospital - Mineola, New York 38.5 miles Julie DiGregorio CCRP 516-663-9614 jdigregorio@winthrop.org

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