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TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

NCT04558775 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 418

Last updated 2023-07-21

No results posted yet for this study

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.

Conditions

  • Diabetes
  • Diabetic Foot
  • Diabetic Foot Ulcer
  • Diabetic Wound
  • Diabetic

Interventions

OTHER

Observational

no intervention

Sponsors & Collaborators

Principal Investigators

  • Chandan K Sen, PhD · Indiana University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04558775 on ClinicalTrials.gov