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

April 24, 2023 updated by: Winthrop University Hospital

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other: Comprehensive Neuropathy Assessment
Standard Monofilament Exam, Vibration Assessment, and Temperature Assessment will be performed on all patients in all study groups.
Other: 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.
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.
Other: 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.
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.
Other: Comprehensive Neuropathy Assessment
Standard Monofilament Exam, Vibration Assessment, and Temperature Assessment will be performed on all patients in all study groups.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Winthrop University Hospital

Investigators

  • Principal Investigator: Mark Stecker, MD, PhD, Winthrop University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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