TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

418 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-17

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetic Foot Diabetic Foot Ulcer Diabetic Wound Diabetic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Cohort

Observational

Intervention Type OTHER

no intervention

Interventions

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Observational

no intervention

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No