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

NCT02329366 | Completed

• 1 other identifier: 14328
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diabetic Foot Ulcer Group

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

Other: Specimen Collection

Control Group

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

Other: Specimen Collection

Interventions

Specimen Collection 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; Diabetic Foot Ulcer Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both male and female patients at Winthrop University Hospital over the age of 18 with Type 2 Diabetes and a Diabetic Foot Ulcer are eligible for enrollment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

In this study, diabetic patients undergoing Diabetic Foot Ulcer debridement under the standard of care will be asked for their permission to collect the debrided tissue for use in scientific research.

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Harold Brem, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2020
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

US (1)