RecruitingNCT06598241

Mirragen Diabetic Foot Ulcer Study

A Pilot, Post-market, Non-interventional, Prospective, Observational Study of Standard of Care of the Commercially Available Borate-base Bioactive Glass Fiber Matrix (BBGFM) in Treatment of Outpatient Diabetic Foot Ulcer With Chronic Osteomyelitis.


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

20 participants

Start Date

Sep 20, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Borate-base Bioactive Glass Fiber Matrix (BBGFM) for people with diabetic foot ulcer and osteomyelitis chronic. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBorate-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.


Locations(1)

UT Health Medical Arts and Research Center

San Antonio, Texas, United States

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NCT06598241


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