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.
The University of Texas Health Science Center at San Antonio
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.
Description
While participants are taking part in this study, they will be asked to attend approximately 12 weekly visits, or until the ulcer has healed. After the ulcer has healed there will be two follow up visits for confirmation, these visits are two weeks apart. Visits with the researchers and/or study staff will last for 16 weeks or less. Participants will continue and complete regular follow-up visit with their treating doctor while participating in this study. The purpose of this study is to collect information about the product safety and efficacy of real-world scenarios on treating diabetic foo…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The subject has signed the informed consent form 2. Subject is male or female aged between ≥ 18 or ≤ 80 3. Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer 4. Index ulcer has not received an application of BBFGM previously 5. Subjects with insurance coverage for BBGFM 6. Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment. 7. The subject is under the care of Physician for the management of Diabetes Mellitus 8. Subject must have a wound pres…
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.
Location
- UT Health Medical Arts and Research CenterSan Antonio, Texas