Mirragen Diabetic Foot Ulcer Study
NCT06598241 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20
Last updated 2025-05-22
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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