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

NCT02347709 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-04-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Winthrop University Hospital

    lead OTHER

Principal Investigators

  • Mark Stecker, MD, PhD · Winthrop University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02347709 on ClinicalTrials.gov