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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Complete Wound Closure
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Detailed 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 foot ulcers. The data that will be collected will help understand long-term risk and benefit from a real-world population.
Investigators
Eligibility Criteria
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
- •Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2
- •Index ulcer has been present for greater than 4 weeks prior to enrollment and less than 2-years, as of the date the subject receives the BBGFM
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
- •Subject is pregnant or breast-feeding.
- •Subject index ulcer associated with carcinoma.
- •Subject has active Charcot Neuroarthropathy
- •Subject requires extensive soft tissue and bone debridement in the operating room
Outcomes
Primary Outcomes
Complete Wound Closure
Time Frame: Week 12
Number of patients to achieve complete wound closure. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
Secondary Outcomes
- 60% Reduction in wound size(Baseline to 12 weeks)
- Pain level using Visual Analog Scale(Baseline to 12 weeks)
- Change in Lower Extremity Function Scale (LEFS )(Baseline to 12 weeks)
- Number of Adverse Events related to BBGFM(Baseline to 12 weeks)
- Number of subjects with either cellulitis, infection and/or osteomyelitis(Baseline to 12 weeks)
- Timing to achieve 100% granulation coverage of wound surface(Baseline to 12 weeks)
- Number of Applications to achieve 100% granulation coverage of wound surface(Baseline to 12 weeks)
- Hospitalization rate for wound related events(Baseline to 12 weeks)
- Number of Amputations(Baseline to 12 weeks)