TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

Completed

• Conditions: Diabetic Foot; Diabetic Wound; Diabetes; Diabetic Foot Ulcer; Diabetic
• Interventions: Other: Observational

• Registration Number: NCT04558775
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-06-17
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-22
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 418

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).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Cohort	Observational	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinician assessment of DFU wound recurrence	16 weeks	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.
Participant self-report of DFU wound recurrence	16 weeks
Time to DFU wound recurrence after complete wound healing	Up to 16 weeks after wound closure

Trial Locations

Locations (6)

University of California - San Francisco; 🇺🇸 San Francisco, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States