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



Status:Recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2014
End Date:December 2020
Contact:Julie DiGregorio, CCRP
Email:jdigregorio@winthrop.org
Phone:(516) 663-9614

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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.

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.

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.
We found this trial at
1
site
259 1st St
Mineola, New York 11501
(516) 663-0333
Phone: 516-663-9614
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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from
Mineola, NY
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