WithdrawnNot Applicable

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

Stopped: PI departure

United States0Started 2014-12

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Measure the degree of loss of epidermal nerve fibers near a lower extremity diabetic wound using Intra-epidermal Nerve Fiber Density analysis.

Timeframe: Three years

Trial details

NCT IDNCT02347709

SponsorWinthrop University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-12-01

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials