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Completed

NCT Number: NCT04558775

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). 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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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Diabetic Wound Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California - San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria at Visit 1:

  • Age > 18 years.
  • Willing and able to comply with protocol instructions.
  • Clinically diagnosed DFU is closed.
  • Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
  • Provides written informed consent.

At Visit 2, confirmation of complete wound healing, the following additional inclusion criterion must be met:

  • 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:

  • DFU wounds closed more than 2 weeks before Visit 1, or to be closed by flap or graft coverage
  • Closed DFU site whose size or location would not allow five separate TEWL measurements
  • Prisoners

Treatment and study plan

Observational

Other

no intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to DFU wound recurrence after complete wound healing

    Time frame: Up to 16 weeks after wound closure

  2. Participant self-report of DFU wound recurrence

    Time frame: 16 weeks

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: TEWL

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2020
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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