Mirragen Diabetic Foot Ulcer Study

NCT06598241 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-05-22

No results posted yet for this study

Summary

This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost.

Conditions

  • Diabetic Foot Ulcer
  • Osteomyelitis Chronic

Interventions

DEVICE

Borate-base Bioactive Glass Fiber Matrix (BBGFM)

Bioactive glass materials are biocompatible water-soluble inorganic ceramic materials that release their constituent ions when immersed in body fluids.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Cyaandi R Dove, DPM · The University of Texas Health Science Center at San Antonio

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2026-05-31
Completion
2026-11-30

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 NCT06598241 on ClinicalTrials.gov