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C-myc Biomarker Study for Diabetic Foot Ulcers

NCT04591691 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2024-07-12

No results posted yet for this study

Summary

This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Marjana Tomic-Canic · University of Miami

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2023-07-20
Completion
2023-07-20

Countries

  • United States

Study Locations

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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 NCT04591691 on ClinicalTrials.gov