Mirragen Diabetic Foot Ulcer Study

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06598241
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Borate-base Bioactive Glass Fiber Matrix (BBGFM) — DEVICE
    Bioactive glass materials are biocompatible water-soluble inorganic ceramic materials that release their constituent ions when immersed in body fluids.

Study Details

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.

Key Dates

Start date
Sep 20, 2024
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Diabetic Foot Ulcer Treatment Group
    Male or female between ≥ 18 years and ≤ 80 years of age that are scheduled to receive treatment of the commercially available borate-based bioactive glass fiber matrix will be enrolled in the study

Primary Outcome Measure

Complete Wound Closure [ Time Frame: Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Health Medical Arts and Research CenterSan AntonioTexas78229
Arthur Tarricone, DPM
[email protected]
210-567-7000
Nicholas Lucio
[email protected]
210-567-4624
Arthur Tarricone, DPM (PRINCIPAL_INVESTIGATOR)

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By research site
UT Health Medical Arts and Research Center· San Antonio, TX

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