Differential Characteristics of Neuropathy in Type 2 Diabetics With and Without Lower Extremity Wounds
NCT ID: NCT02347709
Last Updated: 2023-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2014-12-31
2017-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Type 2 Diabetes defined as HgA1c ≥ 5.9%
* Must be willing and able to provide written Informed Consent
Exclusion Criteria
* Gangrene
* Purulent drainage
* Any experimental drugs applied topically or taken by mouth within 4 weeks of study entry
* INR \> 2.5
18 Years
ALL
No
Sponsors
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Winthrop University Hospital
OTHER
Responsible Party
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Principal Investigators
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Mark Stecker, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Winthrop University Hospital
Locations
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Winthrop University Hospital
Mineola, New York, United States
Countries
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Other Identifiers
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14024
Identifier Type: -
Identifier Source: org_study_id
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