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

NYU Langone Hospitals

Status: Withdrawn

Conditions: Diabetic Neuropathy; Type 2 Diabetes; Diabetic Foot Ulcer

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

Study type: Observational

Funder types: Other

Identifiers

NCT02347709

14024

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

Group 1/Diabetic Foot Ulcer

Description:

Group 1 will be recruited from the Wound Center, and will include patients with a diagnosis of Type 2 Diabetes (defined as HgA1c ≥5.9%), and a diabetic foot ulcer (defined as a break in the skin on the foot). Subjects in this group will complete a survey, undergo a Comprehensive Neuropathy Evaluation, and have a photograph and biopsy of their Diabetic Foot Ulcer in addition to the standard of care.

Treatment:

Other: Survey

Procedure: Diabetic Foot Ulcer Biopsy

Other: Wound Photography

Other: Comprehensive Neuropathy Assessment

Group 2/Diabetic Neuropathy

Description:

Group 2 will be recruited from the Neurology clinic and will include patients with a diagnosis of Type 2 Diabetes (defined as HgA1c ≥ 5.9%) and neuropathy. Subjects in this group will complete a survey and undergo a Comprehensive Neuropathy Evaluation in addition to the standard of care.

Treatment:

Other: Survey

Other: Comprehensive Neuropathy Assessment

Group 3/Type 2 Diabetes

Description:

Group 3 will be recruited from the Endocrinology clinic and will include patients with a diagnosis of Type 2 Diabetes (defined as HgA1c ≥ 5.9%) who currently do not have a diagnosis of neuropathy or a diabetic foot ulcer. Subjects in this group will complete a survey and undergo a Comprehensive Neuropathy Evaluation in addition to the standard of care.

Treatment:

Other: Survey

Other: Comprehensive Neuropathy Assessment