Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Michael Conte, MD
Photo of Michael Conte
Michael Conte

Description

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.

Official Title

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

Keywords

Diabetes Diabetic Foot Diabetic Foot Ulcer Diabetic Wound Diabetic biomarker TEWL trans epidermal water loss DFC Diabetic Foot Consortium Foot Ulcer Ulcer Recurrence

Eligibility

You can join if…

Open to people ages 18 years and up

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. Diagnosis of diabetes, per American Diabetes Association (ADA) guidelines:
  5. Fasting plasma glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours*, OR
  6. 2-hour plasma glucose (PG) ≥ 200 mg/dL (11.1 mmol/L) during oral glucose tolerance test (OGTT). The test should be performed as described by the World Health Organization (WHO), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water*, OR
  7. A1C ≥ 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the Diabetes Control and Complications Trial (DCCT) assay*, OR
  8. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).

[* In the absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results from the same sample or in two separate test samples.]

  1. Provides written informed consent.

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

  1. Confirmation that the target DFU that was assessed as healed at Visit 1 remains healed two weeks later (at Visit 2).

You CAN'T join if...

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

Locations

  • University of California - San Francisco accepting new patients
    San Francisco California 94143 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Lead Scientist at UCSF

  • Michael Conte, MD
    Professor, Surgery. Authored (or co-authored) 254 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
ID
NCT04558775
Study Type
Observational
Last Updated