TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

Diabetes Clinical Trial

— TEWL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558775
• Other study ID #: HUM00176334
• Secondary ID: 1U24DK122927-01
• Status: Completed
• Start date: June 17, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetic
• Diabetic Foot
• Diabetic Foot Ulcer
• Diabetic Wound
• Foot Ulcer
• Recurrence
• Ulcer

Intervention

Other:
• Observational
no intervention

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Indiana University	Indianapolis	Indiana
United States	University of Miami	Miami	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California - San Francisco	San Francisco	California
United States	Stanford University	Stanford	California

Sponsors (7)

Lead Sponsor	Collaborator
University of Michigan	Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, University of California, San Francisco, University of Miami, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing		1 up to 16 weeks after wound closure
Secondary	Time to DFU wound recurrence after complete wound healing		Up to 16 weeks after wound closure
Secondary	Participant self-report of DFU wound recurrence		16 weeks
Secondary	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