TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

University of Michigan

Status: Completed

Conditions: Diabetic; Diabetic Foot; Diabetes; Diabetic Wound; Diabetic Foot Ulcer

Treatments: Other: Observational

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04558775

HUM00176334

1U24DK122927-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 418 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.

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

Trial design

418 participants in 1 patient group

Observational Cohort

Treatment:

Other: Observational