TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence
Public ClinicalTrials.gov record NCT04558775. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Tran-epidermal Water Loss (TEWL) as a Predictive Marker for Diabetic Foot Ulcer (DFU) Recurrence
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04558775
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 418 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 16, 2020
- Primary completion
- Dec 29, 2022
- Completion
- Dec 29, 2022
- Last update posted
- Jul 20, 2023
2020 – 2022
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California - San Francisco | San Francisco | California | 94143 | — |
| Stanford University | Stanford | California | 94305 | — |
| University of Miami | Miami | Florida | 33126 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 25261 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04558775, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04558775 live on ClinicalTrials.gov.