Diabetic Foot UlcerH2H-DFUNCT03232333
MIRODERM H2H DFU Study
An observational study of Diabetic Foot Ulcer, run by Miromatrix Medical Inc. at 9 sites in United States.
Trial summary
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Biologic wound graft
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Jul 2017to 20 Sep 2018
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All patients who have at least one small to moderately sized diabetic foot ulcer and have been undergoing extended and unsuccessful treatment, as defined by failure of the wound to completely close over the previous 3 months and after application of at least 2 biological products.
Who may be able to join
- 18 years old or older at time of initial visit
- Have Type I or Type II diabetes
- Have a neuropathic diabetic foot ulcer with the following characteristics:
- Is greater than 1 cm2 and less than or equal to 12 cm2
- Has failed to close following at least 2 treatments with a biologic
- Has been present for 90 days or longer
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- Does not show signs of infection
- Is full thickness (Wagner Grade I or II)
- Located distal to the malleolus
- Depth of less than or equal to 5 mm
- No exposed capsule, tendon or bone
- No tunneling, undermining or sinus tracts
- Not between the toes
- Be willing and able to maintain required off-loading of affected limb
- Be willing and able to perform necessary dressing changes
- Have at least one of the following:
- An Ankle-brachial index (ABI) ≥ 0.8
- TcPO2 of ≥ 30 mmHg
- A toe pressure of ≥ 50 mmHg
Who cannot join
- Be pregnant or be planning to become pregnant during the study
- Have had a Chopart's Amputation (or higher)
- Have a history of bone cancer of the affected limb
- Be undergoing dialysis
- Have active osteomyelitis or be receiving treatment for osteomyelitis
- Be diagnosed with unstable Charcot Foot on the affected side
Show all 13Show fewer
- Have an HbA1c level of ≥ 12% within the past 90 days
- Have another ulcer within 2 cm of the study ulcer
- Be immunocompromised or at risk of immunosuppression as determined by the treating investigator
- Have a known collagen vascular disease or connective tissue disease
- Have received treatment of the study ulcer with a skin substitute product or topical growth factor within the past 4 weeks
- Be participating in another medical research study
- Have a sensitivity to porcine material
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
American Health Network
Avon, Indiana, 46123
ILD Research
Carlsbad, California, 92009
A Step Ahead Foot Care
Mount Vernon, New York, 10550
Gramercy Park Podiatry
New York, New York, 10010
Foot Associates of New York
New York, New York, 10022
Kansas City Institute of Podiatry
Overland Park, Kansas, 66125
St. Anthony's Wound Care Center
St Louis, Missouri, 63128
Foot and Ankle Institute
St. George, Utah, 84770
Bond Clinic / Clinical Reseach of Central Florida
Winter Haven, Florida, 33880
About this study
Official title: Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
Read the detailed description
The primary objective of this study is to determine the number of successful complete wound closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some secondary objectives of this study include documenting the time course of wound healing and assessing changes in quality of life.
The primary cohort is individuals suffering from a diabetic foot ulcer that has not been healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle, and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes with adequate vascular profusion. Subjects will be unable to participate if they have osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are immunocompromised or have an HbA1c level equal to or great than 12%.
This is a single-arm study with no Independent Variables. Descriptive data to be collected will include demographics, pathology and medical history.
Outcome assessments:
- proportion of subjects with 100% epithelialization of wound
- SF-36
- Adverse events
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Biologic wound graft
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic wound graftDevice
Also called MIRODERM Biologic Wound Matrix treatment
Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix
| Study group | Role | What they receive |
|---|---|---|
| MIRODERM | Biologic wound graft Receives: Device: Biologic wound graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants
Percentage of participants with healed ulcers within 12 weeks of treatment
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 posted28 Jul 2017
- Study start21 Jul 2017
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
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.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miromatrix Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Fridman, DPM, Principal investigator, Foot Associates of New YorkM Mason Macenski, PhD, Study director, Miromatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232333
- Sponsor's protocol ID
- 2016002
- Acronym
- H2H-DFU
- Status last verified
- Oct 2019
- First submitted
- 25 Jul 2017
- Last updated
- 22 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03232333
- Acronym / sponsor ID
- H2H-DFU / 2016002
- Conditions
- Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Miromatrix Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Posted 9 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
Detailed description
The primary objective of this study is to determine the number of successful complete wound closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some secondary objectives of this study include documenting the time course of wound healing and assessing changes in quality of life.
The primary cohort is individuals suffering from a diabetic foot ulcer that has not been healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle, and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes with adequate vascular profusion. Subjects will be unable to participate if they have osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are immunocompromised or have an HbA1c level equal to or great than 12%.
This is a single-arm study with no Independent Variables. Descriptive data to be collected will include demographics, pathology and medical history.
Outcome assessments:
- proportion of subjects with 100% epithelialization of wound
- SF-36
- Adverse events
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIRODERM | – | Device: Biologic wound graftBiologic wound graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who have at least one small to moderately sized diabetic foot ulcer and have been undergoing extended and unsuccessful treatment, as defined by failure of the wound to completely close over the previous 3 months and after application of at least 2 biological products.
Key inclusion criteria (19 listed)
- 18 years old or older at time of initial visit
- Have Type I or Type II diabetes
- Have a neuropathic diabetic foot ulcer with the following characteristics:
- Be willing and able to maintain required off-loading of affected limb
- Be willing and able to perform necessary dressing changes
Key exclusion criteria (13 listed)
- Be pregnant or be planning to become pregnant during the study
- Have had a Chopart's Amputation (or higher)
- Have a history of bone cancer of the affected limb
- Be undergoing dialysis
- Have active osteomyelitis or be receiving treatment for osteomyelitis
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 |
|---|---|---|
| Biologic wound graftAlso: MIRODERM Biologic Wound Matrix treatmentDiabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix | Device | MIRODERM |
Primary outcome
Percentage of Participants
Time frame: 12 weeks
Percentage of participants with healed ulcers within 12 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert Fridman, DPM principal investigator
Foot Associates of New York
M Mason Macenski, PhD study director
Miromatrix
9 sites 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, run by Miromatrix Medical Inc. at 9 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 19 inclusion and 13 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 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 9 Oct 2019). 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?
Percentage of Participants (time frame: 12 weeks). 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 22 Oct 2019.