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
This trial does not accept healthy volunteersQualifiers
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 population
Patients who are scheduled to receive treatment of commercially available borate-based bioactive glass fiber matrix (BBGFM) at the Medical Arts and Research Center (MARC) and Texas Diabetes Institute (TDI) will be considered potential subjects and will be pre-screened.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Borate-base Bioactive Glass Fiber Matrix (BBGFM)
DeviceBioactive glass materials are biocompatible water-soluble inorganic ceramic materials that release their constituent ions when immersed in body fluids.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Diabetic Foot Ulcer Treatment Group1 intervention
Trial outcomes
Primary outcomes
1
Complete Wound Closure
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.
Time frame
Week 12Secondary outcomes
1
60% Reduction in wound size
Percentage of subjects achieving greater than or equal to 60 % reduction in wound area and depth from enrollment visit to 12 weeks, measured weekly with standard ruler and iPhone "Measure" app
Time frame
Baseline to 12 weeks2
Pain level using Visual Analog Scale
Change in pain levels during trial, using the Visual Analog Scale which measure pain on range of 0 to 10, zero being no pain and 10 being the most severe pain.
Time frame
Baseline to 12 weeks3
Change in Lower Extremity Function Scale (LEFS )
The Lower Extremity Functional Scale (LEFS) is a 20-item questionnaire that measures a person's disability in activities related to their lower extremities. The scale is scored on a scale of 0 to 80, with higher scores indicating less disability.
Time frame
Baseline to 12 weeks4
Number of Adverse Events related to BBGFM
Mean number of adverse events experienced by participants related to the treatment
Time frame
Baseline to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov