TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

• Sponsor: University of Michigan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04558775
• Collaborator: Indiana University (Other), Stanford University (Other), University of Miami (Other), University of Pittsburgh (Other), University of California, San Francisco (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 402
• Locations: 6
• Anticipated Duration (Months): 27.4
• Patients Per Site: 67
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetic Foot; Diabetic Foot Ulcer; Diabetic Wound; Diabetic	Other: Observational

Study Design

• Study Type: Observational
• Anticipated Enrollment: 402 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Tran-epidermal Water Loss (TEWL) as a Predictive Marker for Diabetic Foot Ulcer (DFU) Recurrence
• Actual Study Start Date: Jun 17, 2020
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Observational Cohort	Other: Observational; no intervention

Outcome Measures

Primary Outcome Measures

1. Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing [1 up to 16 weeks after wound closure]

Secondary Outcome Measures

1. Time to DFU wound recurrence after complete wound healing [Up to 16 weeks after wound closure]

2. Participant self-report of DFU wound recurrence [16 weeks]

3. Clinician assessment of DFU wound recurrence [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California - San Francisco	San Francisco	California	United States	94143
2	Stanford University	Stanford	California	United States	94305
3	University of Miami	Miami	Florida	United States	33126
4	Indiana University	Indianapolis	Indiana	United States	46202
5	University of Michigan	Ann Arbor	Michigan	United States	48109
6	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	25261

Sponsors and Collaborators

• University of Michigan
• 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)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cathie Spino, ScD, Research Professor of Biostatistics, SABER Director, University of Michigan
• ClinicalTrials.gov Identifier: NCT04558775
• Other Study ID Numbers: HUM00176334; 1U24DK122927-01
• First Posted: Sep 22, 2020
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cathie Spino, ScD, Research Professor of Biostatistics, SABER Director, University of Michigan: biomarker; TEWL; trans epidermal water loss; DFC; Diabetic Foot Consortium
• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer; Recurrence

Study Results

No Results Posted as of Mar 17, 2022