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

Withdrawn

• Conditions: Type 2 Diabetes; Diabetic Foot Ulcer; Diabetic Neuropathy
• Interventions: Procedure: Diabetic Foot Ulcer Biopsy; Other: Survey; Other: Comprehensive Neuropathy Assessment; Other: Wound Photography

• Registration Number: NCT02347709
• Lead Sponsor: Winthrop University Hospital

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-27
• Status Verified: 2015-12
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1/Diabetic Foot Ulcer	Survey	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.
Group 2/Diabetic Neuropathy	Survey	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.
Group 2/Diabetic Neuropathy	Comprehensive Neuropathy Assessment	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.
Group 1/Diabetic Foot Ulcer	Wound Photography	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.
Group 1/Diabetic Foot Ulcer	Comprehensive Neuropathy Assessment	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.
Group 3/Type 2 Diabetes	Survey	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.
Group 1/Diabetic Foot Ulcer	Diabetic Foot Ulcer Biopsy	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.
Group 3/Type 2 Diabetes	Comprehensive Neuropathy Assessment	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States