Trials / Completed
CompletedNCT04558775
TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence
Tran-epidermal Water Loss (TEWL) as a Predictive Marker for Diabetic Foot Ulcer (DFU) Recurrence
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 418 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational | no intervention |
Timeline
- Start date
- 2020-06-17
- Primary completion
- 2022-12-30
- Completion
- 2022-12-30
- First posted
- 2020-09-22
- Last updated
- 2023-07-21
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04558775. Inclusion in this directory is not an endorsement.