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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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
. Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation
. Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application