DiabetesTEWLNCT04558775
TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence
An observational study of Diabetes and Diabetic Foot, run by University of Michigan at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- What is being tested?
- Observational
- How many people
- 418 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Jun 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult diabetic patients with diabetic foot ulcer
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Indiana University
Indianapolis, Indiana, 46202
University of Miami
Miami, Florida, 33126
University of Pittsburgh
Pittsburgh, Pennsylvania, 25261
University of California - San Francisco
San Francisco, California, 94143
Stanford University
Stanford, California, 94305
About this study
Official title: 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.
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Wound, Diabetic
- Being tested
- Observational
- Keywords
- biomarker, TEWL, trans epidermal water loss, DFC, Diabetic Foot Consortium
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing
Measured: 1 up to 16 weeks after wound closure
Secondary outcomes (3)
Time to DFU wound recurrence after complete wound healing
Measured: Up to 16 weeks after wound closure
Participant self-report of DFU wound recurrence
Measured: 16 weeks
Clinician assessment of DFU wound recurrence
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start17 Jun 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Stanford University, University of Miami, University of Pittsburgh, University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Cathie Spino, ScD, University of Michigan
- Investigators
- Chandan K Sen, PhD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558775
- Sponsor's protocol ID
- HUM00176334
- Other IDs
- 1U24DK122927-01
- Acronym
- TEWL
- Status last verified
- Jul 2023
- First submitted
- 16 Sep 2020
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tran-epidermal Water Loss (TEWL) as a Predictive Marker for Diabetic Foot Ulcer (DFU) Recurrence
- ClinicalTrials.gov ID
- NCT04558775
- Acronym / sponsor ID
- TEWL / HUM00176334
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Wound, Diabetic
- Keywords
- biomarker, TEWL, trans epidermal water loss, DFC, Diabetic Foot Consortium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Indiana University, Stanford University, University of Miami, University of Pittsburgh, University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Other: Observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult diabetic patients with diabetic foot ulcer
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationalno intervention | Other | Observational Cohort |
Primary outcome
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
3 secondary outcomes
Time to DFU wound recurrence after complete wound healing
Time frame: Up to 16 weeks after wound closure
Participant self-report of DFU wound recurrence
Time frame: 16 weeks
Clinician assessment of DFU wound recurrence
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandan K Sen, PhD study chair
Indiana University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetic Foot, run by University of Michigan at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.