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NCT04558775 · ClinicalTrials.gov registry record

TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

A clinical trial, sponsored by University of Michigan.

Completed
Registry status
418
Enrollment target

NCT04558775: Completed study, sponsored by University of Michigan.

NCT04558775 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 418 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04558775 has completed, sponsored by University of Michigan.

COMPLETED
Registry status
418 participants
Enrollment target

Study 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.

Interventions

  • OTHER Observational

Trial Details

FieldValue
Enrollment Target 418 participants
Start Date 2020-06-17
Est. Completion 2022-12-30
University of Michigan

1,327 total trials

What the finished NCT04558775 record still lists

NCT04558775 is an observational study that tracks outcomes without assigning an intervention. The registered 418 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Observational is the first listed.

NCT04558775 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04558775 about?

NCT04558775 is a clinical study titled "TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence". 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). ...

What is the current status of trial NCT04558775?

This trial is currently completed. The enrollment target is 418 participants. The study started on 2020-06-17. Estimated completion is 2022-12-30.

What interventions are being tested in trial NCT04558775?

The interventions under investigation include: Observational (OTHER).

Who is sponsoring clinical trial NCT04558775?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04558775, the US trial registry maintained by the National Library of Medicine. NCT04558775 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.