Clinical trial NCT04558775: TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence
Official title: Tran-epidermal Water Loss (TEWL) as a Predictive Marker for Diabetic Foot Ulcer (DFU) Recurrence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetic Foot
Diabetic Foot Ulcer
Diabetic Wound
Diabetic
Keywords: biomarker
TEWL
trans epidermal water loss
DFC
Diabetic Foot Consortium
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Indiana University
name: Stanford University
name: University of Miami
name: University of Pittsburgh
name: University of California, San Francisco
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-09-22
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult diabetic patients with diabetic foot ulcer

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing
timeFrame: 1 up to 16 weeks after wound closure
Secondary outcomes:
measure: Time to DFU wound recurrence after complete wound healing
timeFrame: Up to 16 weeks after wound closure
measure: Participant self-report of DFU wound recurrence
timeFrame: 16 weeks
measure: Clinician assessment of DFU wound recurrence
timeFrame: 16 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Indiana University
name: Chandan K Sen, PhD
role: STUDY_CHAIR
References: