TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence (TEWL)

July 19, 2023 updated by: Cathie Spino, ScD, University of Michigan

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

418

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California - San Francisco
      • Stanford, California, United States, 94305
        • Stanford University
    • Florida
      • Miami, Florida, United States, 33126
        • University of Miami
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 25261
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult diabetic patients with diabetic foot ulcer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational Cohort
Other: Observational
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing
Time Frame: 1 up to 16 weeks after wound closure
1 up to 16 weeks after wound closure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to DFU wound recurrence after complete wound healing
Time Frame: Up to 16 weeks after wound closure
Up to 16 weeks after wound closure
Participant self-report of DFU wound recurrence
Time Frame: 16 weeks
16 weeks
Clinician assessment of DFU wound recurrence
Time Frame: 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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

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

Investigators

  • Study Chair: Chandan K Sen, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2020

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00176334
  • 1U24DK122927-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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