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CompletedNCT02329366Updated Apr 26, 2023

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

An observational study in Diabetic Foot Ulcer and Type 2 Diabetes, sponsored by Winthrop University Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.

Sponsored by Winthrop University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Foot Ulcer
  • Type 2 Diabetes
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherSpecimen 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.

05

What researchers measure

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

    Time frame: Undetermined

06

Study locations

1 site
  • Winthrop University Hospital
    Mineola, New York 11501, United States
07

Registry details

Key details

Study ID
NCT02329366
Lead sponsor
Winthrop University Hospital
Responsible party
Sponsor
First posted
Dec 31, 2014
Start date
Dec 2014
Primary completion
Dec 1, 2017
Completion
Dec 1, 2020
Last update
Apr 26, 2023

Study contacts

Harold Brem, MD
principal investigator · Winthrop University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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