NCT04558775 (TEWL) is a clinical trial of Observational in Diabetes, sponsored by University of Michigan.

Who is sponsoring NCT04558775?

NCT04558775 is sponsored by University of Michigan.

What drugs are being tested in NCT04558775?

Interventions in NCT04558775: Observational.

What condition does NCT04558775 study?

NCT04558775 studies Diabetes, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Wound, Diabetic.

Is NCT04558775 still recruiting?

NCT04558775 is currently completed. Last updated 21 July 2023.

Last reviewed 2023-07-21 · How we verify

NCT04558775: TEWL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

Completed Last updated 21 July 2023

What this trial tests

trial testing Observational in Diabetes in 418 participants. Completed in 30 December 2022.

Timeline

17 June 2020

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	University of Michigan
Status	Completed
Study type	OBSERVATIONAL
Enrollment	418
Start date	17 June 2020
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	6 locations across United States

Drugs / interventions tested

Observational — full drug profile →

Conditions studied

Diabetes — all drugs for Diabetes →
Diabetic Foot — all drugs for Diabetic Foot →
Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
Diabetic Wound — all drugs for Diabetic Wound →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Diabetes or Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

High Transepidermal Water Loss at the Site of Wound Closure Is Associated With Increased Recurrence of Diabetic Foot Ulcers: The NIDDK Diabetic Foot Consortium TEWL Study.
Sen CK, Gordillo GM, Roy S, Jahnke J, et al · · 2025 · cited 8× · PMID 40445117 · DOI 10.2337/dc25-0300
Clinical Measurement of Transepidermal Water Loss.
Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148

Verify or expand the search:

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Other University of Michigan trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04558775 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Michigan
Last refreshed: 21 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04558775.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing