Clinical trial NCT02347709: Differential Characteristics of Neuropathy in Type 2 Diabetics With and Without Lower Extremity Wounds
Official title: Differential Clinical, Molecular, and Pathological Characteristics of Neuropathy in Type 2 Diabetics With and Without Lower Extremity Wounds-a Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetic Foot Ulcer
Diabetic Neuropathy
Type 2 Diabetes
Keywords: Diabetic Foot Ulcer
DFU
Type 2 Diabetes
Neuropathy
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include eligible patients from three Winthrop outpatient services, separated into three study groups. Based on demographic data from this institution, we expect our population sample to be representative of all major races and ethnic groups.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Mark Stecker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: