Diabetic Foot UlcerNCT06403605
Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
A study testing Mirragen Advanced Wound Matrix and Fibracol in people with Diabetic Foot Ulcer and Ulcer Foot, run by ETS Wound Care, LLC at 15 sites in United States.
Trial summary
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- What is being tested?
- Mirragen Advanced Wound Matrix and Fibracol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 15 sitesUnited States
- Study dates
- 13 Sep 2022to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with a photographic planimetry app.
- The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
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- Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
- TCOM ≥30 mmHg
- ABI between 0.7 and 1.3
- PVR: Biphasic
- TBI ˃0.6
- As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle
- If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.
- The subject must consent to using the prescribed off-loading method for the duration of the study.
- The subject must agree to attend the weekly study visits required by the protocol.
- The subject must be willing and able to participate in the informed consent process.
Who cannot join
- A subject known to have a life expectancy of < 6 months is excluded.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
- A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
- The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
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- A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
- If a subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.
- If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
- The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.
- A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
- Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
- A potential subject with end stage renal disease requiring dialysis is excluded.
- A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.
- A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
- A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
United Wound Healing P.S
Auburn, Washington, 98092
Mercy Medical Center
Cedar Rapids, Iowa, 52403
Wound Centrics
Corpus Christi, Texas, 78404
PULSE: Amputation Prevention Center, LLC
El Paso, Texas, 79902
Foot and Ankle Specialists of the Mid Atlantic
Frederick, Maryland, 21703
Southernmost Foot and Ankle Specialists
Homestead, Florida, 33030
Wound Care Experts
Las Vegas, Nevada, 89148
LA Foot and Ankle
Los Angeles, California, 90010
Gateway Clinical Trials
O'Fallon, Illinois, 62269
Casa Colina
Pomona, California, 91769
Foot and Ankle Specialists of the Mid Atlantic
Salem, Virginia, 24153
Center for Clincal Research
San Francisco, California, 94115
Doctor's Research Network
South Miami, Florida, 33143
Foot and Ankle Center of Illinois
Springfield, Illinois, 62704
Lower Extremity Institute for Research and Therapy
Youngstown, Ohio, 44512
About this study
Official title: A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Borate-based Bioactive Glass Advanced Wound Matrix and Standard of Care Versus Standard of Care Alone
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
Read the detailed description
This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.
There are two arms in the study:
Arm 1: SOC therapy (offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with resorbable bioactive glass fiber, MIRRAGEN™ Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
ARM 2: SOC therapy (offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with calcium alginate Fibracol dressing follwed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Being tested
- Mirragen Advanced Wound Matrix, Fibracol
- Keywords
- DFU, Ulcer
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirragen Advanced Wound MatrixDevice
Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief.
Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing.
Mirragen Advanced Wound Matrix - application of Mirragen to wound site along with standard of care treatment.
FibracolDevice
Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief.
Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing.
Fibracol - application of Fibracol to wound site along with standard of care treatment.
| Study group | Role | What they receive |
|---|---|---|
| SOC primary dressing with MIRRAGEN™ | Experimental | Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing. Receives: Device: Mirragen Advanced Wound Matrix |
| SOC primary dressing with FIBRACOL™ | Active comparator | A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing. Receives: Device: Fibracol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Healing
The proportion of subjects achieving complete wound closure.
Measured: 12 weeks
Secondary outcomes (4)
Percentage Area Reduction (PAR)
Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination
Measured: 12 weeks
Time to Heal
The time to achieve complete wound closure within 12 weeks.
Measured: 12 weeks
Changes in Quality of Life
The WOUND-Q is a questionnaire measuring outcomes important to patients with chronic wounds. Five of the tool's 13 independently functioning scales (with 5 to 11 items each) were measured in this study. 'Assessment' measures how concerned someone has been with their wound(s). 'Drainage' measures how bothered someone has been by drainage from their wound(s). 'Smell' measures how bothered someone has been by the smell from their wound(s). 'Social' measures the impact of a person's wound(s) on their social life. 'Dressing' measures someone's satisfaction with their wound dressing. For all of these scales, possible responses to each item range from minimum 0 ('not at all') to maximum 4 ('very much'). To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. The total raw score for the scale is then converted to a score that ranges from 0 to 100. For all, higher scores represent better outcomes.
Measured: 12 weeks
Change in Pain Level
The FACES pain scale was administered to the clinical trial participants at each visit. The trial participant selected their pain level with a series of faces that correspond to a number between 0 which implies no pain, up to 10 which implies the most severe pain.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start13 Sep 2022
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETS Wound Care, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Responsible party
- Sponsor
- Investigators
- David Armstrong, DPM, MD, PhD, Study chair, USC/SalsaCharles M Zelen, DPM, Principal investigator, Professional Education and Research InstituteRobert Galiano, MD, Study chair, Professor of Surgery, Plastic Surgery, Northwestern University School of Medicine, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403605
- Sponsor's protocol ID
- ETS-MG-DFU-02
- Status last verified
- Oct 2025
- First submitted
- 3 May 2024
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Armstrong DG, Orgill DP, Galiano RD, Lantis J, Glat PM, Gitterle M, Carter MJ, Young N, Zelen CM. A Borate-Based Bioactive Glass Advances Wound Healing in Non-Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial. Int Wound J. 2025 Oct;22(10):e70763. doi: 10.1111/iwj.70763.
PubMed 41014175
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Borate-based Bioactive Glass Advanced Wound Matrix and Standard of Care Versus Standard of Care Alone
- ClinicalTrials.gov ID
- NCT06403605
- Acronym / sponsor ID
- ETS-MG-DFU-02
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Keywords
- DFU, Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- ETS Wound Care, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Posted 10 Nov 2025
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 a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
Detailed description
This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.
There are two arms in the study:
Arm 1: SOC therapy (offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with resorbable bioactive glass fiber, MIRRAGEN™ Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
ARM 2: SOC therapy (offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with calcium alginate Fibracol dressing follwed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC primary dressing with MIRRAGEN™ | Experimental | Device: Mirragen Advanced Wound MatrixMirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing. |
| SOC primary dressing with FIBRACOL™ | Active comparator | Device: FibracolA commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with a photographic planimetry app.
- The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
Key exclusion criteria (16 listed)
- A subject known to have a life expectancy of < 6 months is excluded.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
- A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
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 |
|---|---|---|
| Mirragen Advanced Wound MatrixOffloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Mirragen Advanced Wound Matrix - application of Mirragen to wound site along with standard of care treatment. | Device | SOC primary dressing with MIRRAGEN™ |
| FibracolOffloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Fibracol - application of Fibracol to wound site along with standard of care treatment. | Device | SOC primary dressing with FIBRACOL™ |
Primary outcome
Complete Wound Healing
Time frame: 12 weeks
The proportion of subjects achieving complete wound closure.
4 secondary outcomes
Percentage Area Reduction (PAR)
Time frame: 12 weeks
Time to Heal
Time frame: 12 weeks
Changes in Quality of Life
Time frame: 12 weeks
Change in Pain Level
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41014175Armstrong DG, Orgill DP, Galiano RD, Lantis J, Glat PM, Gitterle M, Carter MJ, Young N, Zelen CM. A Borate-Based Bioactive Glass Advances Wound Healing in Non-Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial. Int Wound J. 2025 Oct;22(10):e70763. doi: 10.1111/iwj.70763.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
David Armstrong, DPM, MD, PhD study chair
USC/Salsa
Charles M Zelen, DPM principal investigator
Professional Education and Research Institute
Robert Galiano, MD study chair
Professor of Surgery, Plastic Surgery, Northwestern University School of Medicine, Chicago, IL
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirragen Advanced Wound Matrix and Fibracol in people with Diabetic Foot Ulcer and Ulcer Foot, run by ETS Wound Care, LLC at 15 sites 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 17 inclusion and 16 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 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403605, which also lists 1 linked publication.
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 10 Nov 2025.