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



Status:Recruiting
Conditions:Diabetic Neuropathy, Neurology, Podiatry, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2014
End Date:December 2017
Contact:Julie DiGregorio, CCRP
Email:jdigregorio@winthrop.org
Phone:(516) 663-9614

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Differential Clinical, Molecular, and Pathological Characteristics of Neuropathy in Type 2 Diabetics With and Without Lower Extremity Wounds-a Pilot Study

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.

Neuropathy is a common complication of diabetes seen in up to 43% of patients with diabetes.
The relationship between neuropathy and diabetic lower extremity wounds is strong and in
fact, 80% of patients with an existing diabetic foot ulcer (DFU) have neuropathy.
Understanding the factors that contribute to the increased risk of wounds in patients with
neuropathy is important in creating optimal strategies to reduce this risk.

Traditionally, the severity of diabetic neuropathy has been evaluated using the clinical
exam and nerve conduction studies. More recently, new techniques such as intra-epidermal
nerve fiber density have shown promise in evaluating neuropathy especially the small nerve
fiber neuropathies that might affect pain sensation and autonomic function. There are also
new molecular markers that may correlate with the risk of neuropathy that may also be useful
in clinically evaluating the diabetic patient with neuropathy.

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.

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
We found this trial at
1
site
259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Mark Stecker, MD, PhD
Phone: 516-663-9614
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mineola, NY
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