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TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence (TEWL)

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ClinicalTrials.gov Identifier: NCT04558775
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Collaborators:
Indiana University
Stanford University
University of Miami
University of Pittsburgh
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Cathie Spino, ScD, University of Michigan

Study Description
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Brief Summary:
This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.

Condition or disease Intervention/treatment
Diabetes Diabetic Foot Diabetic Foot Ulcer Diabetic Wound Diabetic Other: Observational

Study Design
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Study Type : Observational
Estimated Enrollment : 402 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tran-epidermal Water Loss (TEWL) as a Predictive Marker for Diabetic Foot Ulcer (DFU) Recurrence
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational Cohort Other: Observational
no intervention


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing, [ Time Frame: 1 up to 16 weeks after wound closure ]

Secondary Outcome Measures :
  1. Time to DFU wound recurrence after complete wound healing [ Time Frame: Up to 16 weeks after wound closure ]
  2. Participant self-report of DFU wound recurrence [ Time Frame: 16 weeks ]
  3. Clinician assessment of DFU wound recurrence [ Time Frame: 16 weeks ]
    Concordance between participant self-report and clinician assessment of DFU wound recurrence is important to provide confidence in the use of patient-reports for the primary endpoint.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult diabetic patients with diabetic foot ulcer
Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria at Visit 1:

  1. Age > 18 years.
  2. Willing and able to comply with protocol instructions.
  3. Clinically diagnosed DFU is closed.

  4. Diagnosis of diabetes, per American Diabetes Association (ADA) guidelines:

    1. Fasting plasma glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours*, OR
    2. 2-hour plasma glucose (PG) ≥ 200 mg/dL (11.1 mmol/L) during oral glucose tolerance test (OGTT). The test should be performed as described by the World Health Organization (WHO), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water*, OR
    3. A1C ≥ 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the Diabetes Control and Complications Trial (DCCT) assay*, OR
    4. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).

    [* In the absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results from the same sample or in two separate test samples.]

  5. Provides written informed consent.

    At Visit 2, confirmation of complete wound healing, the following additional inclusion criterion must be met:

  6. Confirmation that the target DFU that was assessed as healed at Visit 1 remains healed two weeks later (at Visit 2).

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. DFU wounds closed more than 2 weeks before Visit 1, or to be closed by flap or graft coverage
  2. Closed DFU site whose size or location would not allow five separate TEWL measurements
  3. Prisoners
Contacts and Locations
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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): NCT04558775


Contacts
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Contact: Brandi K Gizinski 7347633632 DFC-DCC-PM@umich.edu
Contact: Jen Mawby 734-763-7810 DFC-DCC-PM@umich.edu

Locations
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United States, California
University of California - San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Christina Kuhrau    415-353-4367    christina.kuhrau@ucsf.edu   
Contact: Manveer Hundal    415-353-4379    manveer.hundal@ucsf.edu   
Principal Investigator: Michael Conte, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Shannon Meyer       smeyer72@stanford.edu   
Principal Investigator: Geoffrey Gurtner, MD, FACS         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33126
Contact: Aliette Espinosa    305-689-3376    a.espinosa2@med.miami.edu   
Contact: Flor MacQuhae    305-689-3376    Fem35@med.miami.edu   
Principal Investigator: Robert S Kirsner, MD, PhD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Bryce Hockman    317-278-2715    bbhockma@iu.edu   
Contact: Bindu Neupane Wagle    317-278-2715    cwcclnrs@iupui.edu   
Principal Investigator: Chandan K Sen, PhD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jacob Reiss    734-763-0177    jereiss@med.umich.edu   
Contact: Aaron Burant    734-615-0552    aburant@med.umich.edu   
Principal Investigator: Rodica Pop-Busui, MD, PhD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 25261
Contact: Center for Innovation and Restorative Medicine    412-641-8676      
Principal Investigator: J. Peter Rubin, MD, FACS         
Sponsors and Collaborators
University of Michigan
Indiana University
Stanford University
University of Miami
University of Pittsburgh
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Chair: Chandan K Sen, PhD Indiana University
More Information
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Responsible Party: Cathie Spino, ScD, Research Professor of Biostatistics, SABER Director, University of Michigan
ClinicalTrials.gov Identifier: NCT04558775    
Other Study ID Numbers: HUM00176334
1U24DK122927-01 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cathie Spino, ScD, University of Michigan:
biomarker
TEWL
trans epidermal water loss
DFC
Diabetic Foot Consortium
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Recurrence
Diabetes Mellitus
Endocrine System Diseases
Pathologic Processes
Disease Attributes
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Foot Diseases