TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

Study Overview
=================
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.

Official Title
-----------------
Tran-epidermal Water Loss (TEWL) as a Predictive Marker for Diabetic Foot Ulcer (DFU) Recurrence

Conditions
-----------------
Diabetes, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Wound, Diabetic

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility 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: Age > 18 years. Willing and able to comply with protocol instructions. Clinically diagnosed DFU is closed. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational Cohort<br> | Other: Observational<br>* no intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing |  | 1 up to 16 weeks after wound closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to DFU wound recurrence after complete wound healing |  | Up to 16 weeks after wound closure | 
| Participant self-report of DFU wound recurrence |  | 16 weeks | 
| Clinician assessment of DFU wound recurrence | 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. | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarker, TEWL, trans epidermal water loss, DFC, Diabetic Foot Consortium