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

Completed

• Conditions: Type 2 Diabetes; Diabetic Foot Ulcer
• Interventions: Other: Specimen Collection

• Registration Number: NCT02329366
• Lead Sponsor: Winthrop University Hospital

Brief 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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-26
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2014-12-31
• Primary Completion: 2017-12-01
• Study Completion: 2020-12-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic Foot Ulcer Group	Specimen Collection	Subjects in this group will have tissue specimens collected from their Diabetic Foot Ulcer during Standard of Care debridement.
Control Group	Specimen Collection	Skin tissue samples will be collected from subjects undergoing routine surgical procedures during which normal skin is removed

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States