An interventional study of Mirragen Advanced Wound Matrix and Fibracol in Diabetic Foot Ulcer, Ulcer Foot and Diabetic Foot, sponsored by ETS Wound Care, LLC. Completed at 15 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by ETS Wound Care, LLC · Not applicable, Interventional, and Treatment
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.
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).
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 148 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →ETS Wound Care, LLC is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Mirragen Advanced Wound Matrix
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.
Device: Fibracol
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.
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.
Complete Wound Healing
The proportion of subjects achieving complete wound closure.
Time frame: 12 weeks
Percentage Area Reduction (PAR)
Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination
Time frame: 12 weeks
Time to Heal
The time to achieve complete wound closure within 12 weeks.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
| Milestone | SOC primary dressing with MIRRAGEN™ | SOC primary dressing with FIBRACOL™ |
|---|---|---|
| Started | 77 | 71 |
| Completed | 77 | 71 |
| Not completed | 0 | 0 |
| Milestone | SOC primary dressing with MIRRAGEN™ | SOC primary dressing with FIBRACOL™ |
|---|---|---|
| Started | 77 | 71 |
| Completed | 52 | 43 |
| Not completed | 25 | 28 |
| Withdrew: Withdrawn per protocol with par <50% at week 6 | 17 | 19 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Withdrawal by subject | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Other reasons | 0 | 4 |
Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination
| percent | SOC primary dressing with MIRRAGEN™ | SOC primary dressing with FIBRACOL™ |
|---|---|---|
| mITT | 48.8 ± 82.81 | 53.7 ± 65.78 |
| PP | 93.7 ± 15.28 | 89.7 ± 25.19 |
The time to achieve complete wound closure within 12 weeks.
| days | SOC primary dressing with MIRRAGEN™ | SOC primary dressing with FIBRACOL™ |
|---|---|---|
| mITT | 63.4 (56.6 to 70.1) | 72.5 (67.3 to 77.7) |
| PP | 57.5 (49.3 to 65.7) | 67.8 (60.5 to 75.2) |
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.
| units on a scale | SOC primary dressing with MIRRAGEN™ | SOC primary dressing with FIBRACOL™ |
|---|---|---|
| Assessment (mITT) | 18.3 ± 20.68 | 17.0 ± 21.36 |
| Drainage (mITT) | 16.6 ± 22.77 | 11.8 ± 20.83 |
| Smell (mITT) | 4.5 ± 23.06 | 1.4 ± 18.42 |
| Social (mITT) | 11.6 ± 28.14 | 15.2 ± 26.27 |
| Dressing (mITT) | 9.0 ± 21.08 | 7.1 ± 18.04 |
| Assessment (PP) | 28.1 ± 17.89 | 24.6 ± 21.34 |
| Drainage (PP) | 25.3 ± 19.58 | 17.6 ± 18.57 |
| Smell (PP) | 8.1 ± 20.73 | 3.4 ± 17.59 |
| Social (PP) | 17.4 ± 29.39 | 19.0 ± 25.53 |
| Dressing (PP) | 14.2 ± 20.85 | 7.7 ± 18.55 |
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.
| score change [EOS - baseline] | SOC primary dressing with MIRRAGEN™ | SOC primary dressing with FIBRACOL™ |
|---|---|---|
| mITT | 0.5 ± 2.47 | 0.8 ± 2.27 |
| PP | 0.9 ± 2.24 | 1.0 ± 2.44 |
The proportion of subjects achieving complete wound closure.
| Participants | SOC primary dressing with MIRRAGEN™ | SOC primary dressing with FIBRACOL™ |
|---|---|---|
| mITT | 32 | 16 |
| PP | 32 | 16 |
Collected over From enrollment until end of follow-up (up to 12 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SOC primary dressing with MIRRAGEN™ | 1/67 (1.5%) | 6/67 (9%) | 5/67 (7.5%) |
| SOC primary dressing with FIBRACOL™ | 0/66 (0%) | 3/66 (4.5%) | 5/66 (7.6%) |
| Event | SOC primary dressing with MIRRAGEN™ | SOC primary dressing with FIBRACOL™ |
|---|---|---|
| Cellulitis, right legInfections and infestations | 0/67 | 1/66 |
| AnasarcaCardiac disorders | 0/67 | 1/66 |
| Bilateral pleural effusionsRespiratory, thoracic and mediastinal disorders | 0/67 | 1/66 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/67 | 1/66 |
| CystitisRenal and urinary disorders | 1/67 | 0/66 |
| Deep space infection of left plantar mid footInfections and infestations | 1/67 | 0/66 |
| Osteomyelitis of sacrumInfections and infestations | 1/67 | 0/66 |
| Postoperative infection of non-study woundInfections and infestations | 1/67 | 0/66 |
| Necrotizing fasciitisInfections and infestations | 1/67 | 0/66 |
| Non-study diabetic foot wound infection with osteomyelitisInfections and infestations | 1/67 | 0/66 |
| Event | SOC primary dressing with MIRRAGEN™ | SOC primary dressing with FIBRACOL™ |
|---|---|---|
| Index wound infectionInfections and infestations | 5/67 | 5/66 |
Both modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
| Age, Continuous(years) | SOC Primary Dressing With MIRRAGEN™ | SOC Primary Dressing With FIBRACOL™ | Total |
|---|---|---|---|
| mITT | 60.1 ± 16.81 | 59.1 ± 14.26 | 59.6 ± 15.50 |
| PP | 60.2 ± 16.34 | 57.7 ± 15.60 | 59.1 ± 15.95 |
| Sex: Female, Male(Participants) | SOC Primary Dressing With MIRRAGEN™ | SOC Primary Dressing With FIBRACOL™ | Total |
|---|---|---|---|
| mITT — Female | 20 | 18 | 38 |
| mITT — Male | 47 | 48 | 95 |
| PP — Female | 11 | 9 | 20 |
| PP — Male | 33 | 29 | 62 |
| Race (NIH/OMB)(Participants) | SOC Primary Dressing With MIRRAGEN™ | SOC Primary Dressing With FIBRACOL™ | Total |
|---|---|---|---|
| mITT — American Indian or Alaska Native | 0 | 0 | 0 |
| mITT — Asian | 1 | 0 | 1 |
| mITT — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| mITT — Black or African American | 7 | 4 | 11 |
| mITT — White | 57 | 60 | 117 |
| mITT — More than one race | 0 | 0 | 0 |
| mITT — Unknown or Not Reported | 2 | 2 | 4 |
| PP — American Indian or Alaska Native | 0 | 0 | 0 |
| PP — Asian | 1 | 0 | 1 |
| PP — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| PP — Black or African American | 5 | 2 | 7 |
| PP — White | 37 | 34 | 71 |
| PP — More than one race | 0 | 0 | 0 |
| PP — Unknown or Not Reported | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | SOC Primary Dressing With MIRRAGEN™ | SOC Primary Dressing With FIBRACOL™ | Total |
|---|---|---|---|
| mITT — Hispanic or Latino | 19 | 14 | 33 |
| mITT — Not Hispanic or Latino | 48 | 52 | 100 |
| mITT — Unknown or Not Reported | 0 | 0 | 0 |
| PP — Hispanic or Latino | 10 | 9 | 19 |
| PP — Not Hispanic or Latino | 34 | 29 | 63 |
| PP — Unknown or Not Reported | 0 | 0 | 0 |
| BMI(kg/m²) | SOC Primary Dressing With MIRRAGEN™ | SOC Primary Dressing With FIBRACOL™ | Total |
|---|---|---|---|
| mITT | 33.9 ± 8.45 | 35.0 ± 8.98 | 34.5 ± 8.71 |
| PP | 34.3 ± 9.06 | 36.4 ± 9.99 | 35.3 ± 9.50 |
| Tobacco use(Participants) | SOC Primary Dressing With MIRRAGEN™ | SOC Primary Dressing With FIBRACOL™ | Total |
|---|---|---|---|
| mITT — Current | 13 | 8 | 21 |
| mITT — Former | 20 | 22 | 42 |
| mITT — Never used tobacco | 34 | 36 | 70 |
| PP — Current | 8 | 4 | 12 |
| PP — Former | 13 | 15 | 28 |
| PP — Never used tobacco | 23 | 19 | 42 |
| Diabetes duration(years) | SOC Primary Dressing With MIRRAGEN™ | SOC Primary Dressing With FIBRACOL™ | Total |
|---|---|---|---|
| mITT | 17.1 ± 13.59 | 15.9 ± 9.58 | 16.5 ± 11.71 |
| PP | 15.7 ± 9.75 | 16.4 ± 14.18 | 16.0 ± 11.93 |
| Age when first DFU appeared(years) | SOC Primary Dressing With MIRRAGEN™ | SOC Primary Dressing With FIBRACOL™ | Total |
|---|---|---|---|
| mITT | 58.2 ± 11.56 | 53.6 ± 11.60 | 55.9 ± 11.76 |
| PP | 58.9 ± 11.86 | 54.4 ± 11.09 | 56.8 ± 11.66 |
26 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2022 to primary completion in Jan 2025, 28 months.
Results were first posted in Nov 2025, 9 months after primary completion.
Of 103 industry-sponsored interventional studies with no phase under Diabetic Foot, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 28 months is above that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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