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

NCT02347709 | Withdrawn

• 1 other identifier: 14024
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer; Diabetic Neuropathy; Type 2 Diabetes

Keywords

Diabetic Foot Ulcer; DFU; Type 2 Diabetes; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Measure the degree of loss of epidermal nerve fibers near a lower extremity diabetic wound using Intra-epidermal Nerve Fiber Density analysis.

  Three years

Study Arms (3)

Group 1/Diabetic Foot Ulcer

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.

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

Group 2/Diabetic Neuropathy

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.

Other: Survey; Other: Comprehensive Neuropathy Assessment

Group 3/Type 2 Diabetes

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.

Other: Survey; Other: Comprehensive Neuropathy Assessment

Interventions

Diabetic Foot Ulcer Biopsy PROCEDURE

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.

Group 1/Diabetic Foot Ulcer

Survey OTHER

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.

Group 1/Diabetic Foot Ulcer; Group 2/Diabetic Neuropathy; Group 3/Type 2 Diabetes

Comprehensive Neuropathy Assessment OTHER

Standard Monofilament Exam, Vibration Assessment, and Temperature Assessment will be performed on all patients in all study groups.

Group 1/Diabetic Foot Ulcer; Group 2/Diabetic Neuropathy; Group 3/Type 2 Diabetes

Wound Photography OTHER

Digital photographs and wound measurements for patients in Study Group 1 will be obtained per standard protocol at baseline and all subsequent visits.

Group 1/Diabetic Foot Ulcer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years
• Type 2 Diabetes defined as HgA1c ≥ 5.9%
• Must be willing and able to provide written Informed Consent

You may not qualify if:

• Active osteomyelitis
• Gangrene
• Purulent drainage
• Any experimental drugs applied topically or taken by mouth within 4 weeks of study entry
• INR \> 2.5

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue samples will be obtained via 3mm punch biopsy during standard of care wound debridement.

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies; Diabetes Mellitus, Type 2

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mark Stecker, MD, PhD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 27, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 26, 2023

Record last verified: 2015-12

Locations

US (1)