Development of a Cellular Biomarker for the Diagnosis and Treatment of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype.

Detailed Description
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The goal of this project is to identify objective, quantitative biological and molecular markers that correlate with healing outcomes for diabetic foot ulcers (DFUs) using debrided tissue of patients with wounds. This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype. The ability to differentiate between healing and non-healing tissue at the onset of wound care will allow for the use of targeted therapies and earlier initiation of aggressive treatments where indicated.

Conditions
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Diabetic Foot Ulcer, Type 2 Diabetes

Intervention / Treatment
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* Other: Specimen Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age ≥ 18 Type 2 Diabetes A break in the skin on the foot ≥ 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system Hemoglobin A1c ≥ 5.9% Ability to provide written informed consent Exclusion Criteria: Any experimental drugs taken orally or topically within 4 weeks of study entry Malignant disease at/or in proximity to the DFU Target wound of malignant origin Failure to satisfy at least one inclusion criterion for one of the two study groups.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic Foot Ulcer Group<br>Subjects in this group will have tissue specimens collected from their Diabetic Foot Ulcer during Standard of Care debridement. | Other: Specimen Collection<br>* . In this study, diabetic patients undergoing DFU debridement under the standard of care will be asked for their permission to collect the debrided tissue for use in scientific research.<br>|
| Control Group<br>Skin tissue samples will be collected from subjects undergoing routine surgical procedures during which normal skin is removed | Other: Specimen Collection<br>* . In this study, diabetic patients undergoing DFU debridement under the standard of care will be asked for their permission to collect the debrided tissue for use in scientific research.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify objective, quantitative biological and molecular markers that correlate with healing outcomes for diabetic foot ulcers (DFUs) using debrided tissue of patients with wounds |  | Undetermined |