Mirragen Diabetic Foot Ulcer Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
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 criteria
Qualifiers
The subject has signed the informed consent form
Subject is male or female aged between ≥ 18 or ≤ 80
Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer
Index ulcer has not received an application of BBFGM previously
Disqualifiers
Subject is unwilling to sign informed consent
Subjects who cannot obtain insurance coverage for BBFGM
The BBFGM cannot be applied in an outpatient setting
Index ulcer has previously received an application of BBFGM
Trial design
Treatments tested in this trial
- Borate-base Bioactive Glass Fiber Matrix (BBGFM)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov