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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329366
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Harold Brem, MD, 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.

Condition or disease Intervention/treatment
Diabetic Foot Ulcer Type 2 Diabetes Other: Specimen Collection

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Time Perspective: Prospective
Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
. 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
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.




Primary Outcome Measures :
  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 ]

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329366


Contacts
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Contact: Julie DiGregorio, CCRP (516) 663-9614 jdigregorio@winthrop.org

Locations
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United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Julie DiGregorio, CCRP    516-663-9614    jdigregorio@winthrop.org   
Sub-Investigator: Julie DiGregorio, CCRP         
Sub-Investigator: Scott Gorenstein, MD         
Principal Investigator: Harold Brem, MD         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
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Principal Investigator: Harold Brem, MD Winthrop University Hospital
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Responsible Party: Harold Brem, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT02329366    
Other Study ID Numbers: 14328
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases