TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence (TEWL)
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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: NCT04558775 |
Recruitment Status :
Recruiting
First Posted : September 22, 2020
Last Update Posted : December 22, 2020
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Condition or disease | Intervention/treatment |
---|---|
Diabetes Diabetic Foot Diabetic Foot Ulcer Diabetic Wound Diabetic | Other: Observational |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Observational Cohort |
Other: Observational
no intervention |
- 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 ]
- Time to DFU wound recurrence after complete wound healing [ Time Frame: Up to 16 weeks after wound closure ]
- Participant self-report of DFU wound recurrence [ Time Frame: 16 weeks ]
- 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.

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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 |
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria at Visit 1:
- Age > 18 years.
- Willing and able to comply with protocol instructions.
- Clinically diagnosed DFU is closed.
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Diagnosis of diabetes, per American Diabetes Association (ADA) guidelines:
- 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-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
- 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
- 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.]
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Provides written informed consent.
At Visit 2, confirmation of complete wound healing, the following additional inclusion criterion must be met:
- 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:
- DFU wounds closed more than 2 weeks before Visit 1, or to be closed by flap or graft coverage
- Closed DFU site whose size or location would not allow five separate TEWL measurements
- Prisoners

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
Contact: Brandi K Gizinski | 7347633632 | DFC-DCC-PM@umich.edu | |
Contact: Jen Mawby | 734-763-7810 | DFC-DCC-PM@umich.edu |
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 |
Study Chair: | Chandan K Sen, PhD | Indiana University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
biomarker TEWL trans epidermal water loss DFC Diabetic Foot Consortium |
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 |