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

NYU Langone Hospitals

Status

Completed

Conditions

Type 2 Diabetes

Diabetic Foot Ulcer

Treatments

Other: Specimen Collection

Study type

Observational

Funder types

Other

Identifiers

NCT02329366

14328

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.