NCT02329366

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Winthrop University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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

• Diabetic Foot Ulcer
• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	Specimen Collection	. 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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-01
• Completion: 2020-12-01
• First posted: 2014-12-31
• Last updated: 2023-04-26

Locations

1 site across 1 country: United States