Diabetic Foot UlcerNCT06598241
Mirragen Diabetic Foot Ulcer Study
An observational study of Diabetic Foot Ulcer and Osteomyelitis Chronic, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer, Osteomyelitis Chronic
- What is being tested?
- Borate-base Bioactive Glass Fiber Matrix (BBGFM)
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to 9 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
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- 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
- The BBGFM will be applied in an outpatient setting
- Subject has an ulcer with a Wagner Grade 2 or 3 classification Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis Wagner Grade 3: Ulcers extend to the deep tissue and have either associated soft tissue abscess or osteomyelitis If Wagner Grade 3 Ulcer with chronic osteomyelitis, that can be debrided in an outpatient setting, in the opinion of the investigator
- Exposed or palpable bone in the reference ulcer, that can be surgically excised in an outpatient clinic setting, using local anesthetic, at the screening or randomization visit
- Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit
- Wagner Grade 3 subjects must have osteomyelitis diagnosed by:
- X-ray: suggestive or positive for changes consistent with chronic osteomyelitis or Positive probe to bone (PTB) test or Strong clinical suspicion, in the opinion of the Investigator, in the presence of osteomyelitis in the index wound
- Subject does not require a surgical debridement in the operating room
- Subjects without active cellulitis at the index ulcer
- Subject or responsible caregiver is willing to comply with the dressing treatment and study visits
- Subject is willing to utilize the offloading device to offload wound
- If female, subjects must have been practicing adequate contraception (abstinence, barrier method, hormonal, or IUD). Must agree to using an accepted and effective form of birth control during the study.
- Subject has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following tests within 60 days (about 2 months) prior to enrollment:
- A.Ankle-Brachial Index (ABI) of study leg(s) of ≥0.7 to ≤1.3 in conjunction with doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg Or B.Toe brachial Index (TBI) of ≥ 0.50 OR C.Great Toe Pressure 50mmHg OR D.Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) of ≥40mmHg on the dorsum of the affected foot OR E.Palpable pulses
Who cannot join
- 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
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- 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
- Subject has a life expectancy of less than six months as assessed by the investigator.
- Subject not in reasonable metabolic control in the judgment of the investigator
- Subject with a known history of poor compliance with medical treatments
- Subject currently undergoing cancer treatment
- Subject has been on oral steroid use of <7.5 mg daily for greater than seven consecutive days in 30 days before screening
- Subject is taking parenteral corticosteroids or any cytotoxic agents for seven consecutive days in the period of 30 days before screening
- The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before screening
- Subject has been diagnosed or had medical history with at least one of the following diseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquired immunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stage renal disease.
- Subject currently receiving radiation therapy or chemotherapy.
- Patient currently on dialysis or planning to start dialysis.
- Presence of any condition that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- Subject is unable to sustain off-loading as defined by the protocol
- Subject index ulcer that cannot be offload by an offloading device
- Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and/or presence of acute cellulitis at the index ulcer
- Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the index ulcer during the study
- Subjects who are permanently non-ambulatory (i.e. wheelchair bound)
- The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner)
- Subject has an allergy to primary or secondary dressing materials used in this trial
- In the opinion of the Investigator the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or subject currently has sepsis, i.e., life threatening organ dysfunction caused by a dysregulated host response to infection
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health Medical Arts and Research Center
San Antonio, Texas, 78229
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer, Osteomyelitis Chronic
- Being tested
- Borate-base Bioactive Glass Fiber Matrix (BBGFM)
- Keywords
- Glass fiber matrix
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Borate-base Bioactive Glass Fiber Matrix (BBGFM)Device
Bioactive glass materials are biocompatible water-soluble inorganic ceramic materials that release their constituent ions when immersed in body fluids.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Foot Ulcer Treatment Group | Male or female between ≥ 18 years and ≤ 80 years of age that are scheduled to receive treatment of the commercially available borate-based bioactive glass fiber matrix will be enrolled in the study Receives: Device: Borate-base Bioactive Glass Fiber Matrix (BBGFM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (9)
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
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
Number of Adverse Events related to BBGFM
Mean number of adverse events experienced by participants related to the treatment
Measured: Baseline to 12 weeks
Number of subjects with either cellulitis, infection and/or osteomyelitis
Total number of subjects that experience any of these infections during study enrollment
Measured: Baseline to 12 weeks
Timing to achieve 100% granulation coverage of wound surface
Number of weeks to achieve complete granulation coverage of ulcer
Measured: Baseline to 12 weeks
Number of Applications to achieve 100% granulation coverage of wound surface
Average number of borate-based bioactive glass fiber matrix applications
Measured: Baseline to 12 weeks
Hospitalization rate for wound related events
Number of participants hospitalized for wound related events during study
Measured: Baseline to 12 weeks
Number of Amputations
Number of subjects requiring amputations during the study.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur Tarricone, DPM, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598241
- Sponsor's protocol ID
- STUDY00000049
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Data will be shared when accepted for publication in a peer-review journal
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06598241
- Acronym / sponsor ID
- STUDY00000049
- Conditions
- Diabetic Foot Ulcer, Osteomyelitis Chronic
- Keywords
- Glass fiber matrix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Foot Ulcer Treatment Group | – | Device: Borate-base Bioactive Glass Fiber Matrix (BBGFM)Male or female between ≥ 18 years and ≤ 80 years of age that are scheduled to receive treatment of the commercially available borate-based bioactive glass fiber matrix will be enrolled in the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Borate-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. | Device | Diabetic Foot Ulcer Treatment Group |
Primary outcome
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.
9 secondary outcomes
60% Reduction in wound size
Time frame: Baseline to 12 weeks
Pain level using Visual Analog Scale
Time frame: Baseline to 12 weeks
Change in Lower Extremity Function Scale (LEFS )
Time frame: Baseline to 12 weeks
Number of Adverse Events related to BBGFM
Time frame: Baseline to 12 weeks
Number of subjects with either cellulitis, infection and/or osteomyelitis
Time frame: Baseline to 12 weeks
Timing to achieve 100% granulation coverage of wound surface
Time frame: Baseline to 12 weeks
Number of Applications to achieve 100% granulation coverage of wound surface
Time frame: Baseline to 12 weeks
Hospitalization rate for wound related events
Time frame: Baseline to 12 weeks
Number of Amputations
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Data will be shared when accepted for publication in a peer-review journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Tarricone, DPM principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Osteomyelitis Chronic, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Wound Closure (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.