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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02347709
• Other study ID #: 14024
• Status: Withdrawn
• Start date: December 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: December 2015
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Foot
• Diabetic Foot Ulcer
• Diabetic Neuropathies
• Diabetic Neuropathy
• Foot Ulcer
• Peripheral Nervous System Diseases
• Type 2 Diabetes

Intervention

Procedure:
• Diabetic Foot Ulcer Biopsy
Specimens from both the wound edge and a distal area of skin of patients will be obtained via 3 mm punch biopsy in the Winthrop University Hospital Wound Care Center. Biopsies will be collected from the wound edge prior to routine debridement using the following standard procedures, including the use of anesthetic if needed.

Other:
• Survey
Study subjects from all three groups will be asked to complete a one-page Focused Neuropathy Evaluation. Providers will complete a one-page Focused Neuropathy Evaluation and a complete neurological examination and sensation assessment.
• Comprehensive Neuropathy Assessment
Standard Monofilament Exam, Vibration Assessment, and Temperature Assessment will be performed on all patients in all study groups.
• Wound Photography
Digital photographs and wound measurements for patients in Study Group 1 will be obtained per standard protocol at baseline and all subsequent visits.

Locations

Country	Name	City	State
United States	Winthrop University Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the degree of loss of epidermal nerve fibers near a lower extremity diabetic wound using Intra-epidermal Nerve Fiber Density analysis.		Three years