Mirragen Diabetic Foot Ulcer Study (NCT06598241) | Clinical Trial Compass
RecruitingNot Applicable
Mirragen Diabetic Foot Ulcer Study
United States20 participantsStarted 2024-09-20
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
✓. Subjects with insurance coverage for BBGFM
✓. Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.
✓. The subject is under the care of Physician for the management of Diabetes Mellitus
✓. Subject must have a wound present anatomically on the foot as defined by beginning below the malleoli of the ankle, dorsal surface, plantar surface, inter digital, heel, lateral or medial surface of the foot
Exclusion criteria
✕. Subject is unwilling to sign informed consent
What they're measuring
1
Complete Wound Closure
Timeframe: Week 12
Trial details
NCT IDNCT06598241
SponsorThe University of Texas Health Science Center at San Antonio