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

NCT ID: NCT02329366

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2020-12-01

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.

Conditions

Diabetic Foot Ulcer; Type 2 Diabetes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetic Foot Ulcer Group

Subjects in this group will have tissue specimens collected from their Diabetic Foot Ulcer during Standard of Care debridement.

Specimen Collection

Intervention Type: OTHER

. 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.

Control Group

Skin tissue samples will be collected from subjects undergoing routine surgical procedures during which normal skin is removed

Specimen Collection

Intervention Type: OTHER

. 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Winthrop University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harold Brem, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Locations

Winthrop University Hospital

Mineola, New York, United States

Countries

United States

Other Identifiers

14328

Identifier Type: -

Identifier Source: org_study_id