Diabetic Foot UlcerNCT06236750
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
A study testing EPIFIX in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by MiMedx Group, Inc. at 5 sites in Japan.
Trial summary
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Leg Ulcer
- What is being tested?
- EPIFIX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesJapan
- Study dates
- 4 Aug 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with intractable diabetic foot ulcers or venous leg ulcers that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies, such as radical wound management (removal of necrotic tissue, infection control, wound cleansing, etc.), glycemic control for diabetic foot ulcers, compression therapy for venous stasis ulcers and moist therapy using wound dressing materials.
Who cannot join
- Areas of active infection or latent infection.
- Patients with disorders that would cause an intolerable risk of postoperative complications.
- Ulcers that cannot be sufficiently debrided.
- Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage.
- Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed.
- Patients with hypersensitivity to the aminoglycoside antibiotics used during manufacturing.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
Juntendo University Hospital
Bunkyō-Ku, Tokyo, 113-8431
- Recruiting
Saitame Medical University Hospital
Iruma-gun, Saitama, 350-0495
- Recruiting
Kobe University Hospital
Kobe, Hyōgo, 650-0017
- Recruiting
Kyorin University Hospital
Mitaka-shi, Tokyo, 181-8611
- Recruiting
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, 160-0023
About this study
Official title: A Post-Marketing Surveillance to Observe the Safety and Efficacy of Dehydrated Human Amnion/Chorion Membrane (DHACM) Wound Graft in the Management of Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
Read the detailed description
The study will enroll 75 subjects diagnosed with intractable diabetic foot ulcers or venous leg ulcers at 5 plastic surgery sites in Japan. Subjects will be treated with weekly applications of EPIFIX for up to 12 weeks, followed by 6 months of follow-up.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Being tested
- EPIFIX
- Medical subject headings
- Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIFIXDevice
Also called DHACM
EPIFIX® is an allograft derived from dehydrated human amnion/chorion membrane. EPIFIX is a medical device in Japan (Generic name: Material using human amniotic membrane for promotion of tissue healing) for use on intractable ulcers that are non-responsive to existing therapies for the purpose of promoting wound healing.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Non-Ischemic Chronic Wounds | Experimental | Patients with intractable diabetic foot ulcer or venous leg ulcer that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies. Receives: Device: EPIFIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks
The percentage of patients to achieve wound closure at 4 weeks, 8 weeks, and 12 weeks after initial DHACM application, as a measure of healing rate.
Measured: 4 weeks, 8 weeks, and 12 weeks after initial application
Safety Endpoint: Incidence of Adverse Events
Incidence rate of adverse events in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.
Measured: 9 months after initial application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start4 Aug 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CMIC Co, Ltd. Japan
- Responsible party
- Sponsor
- Investigators
- David Mason, MD, Study director, MiMedx Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236750
- Sponsor's protocol ID
- EFJP001
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Surveillance to Observe the Safety and Efficacy of Dehydrated Human Amnion/Chorion Membrane (DHACM) Wound Graft in the Management of Non-Ischemic Chronic Wounds
- ClinicalTrials.gov ID
- NCT06236750
- Acronym / sponsor ID
- EFJP001
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CMIC Co, Ltd. Japan
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 Feb 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.
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
Detailed description
The study will enroll 75 subjects diagnosed with intractable diabetic foot ulcers or venous leg ulcers at 5 plastic surgery sites in Japan. Subjects will be treated with weekly applications of EPIFIX for up to 12 weeks, followed by 6 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Non-Ischemic Chronic Wounds | Experimental | Device: EPIFIXPatients with intractable diabetic foot ulcer or venous leg ulcer that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with intractable diabetic foot ulcers or venous leg ulcers that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies, such as radical wound management (removal of necrotic tissue, infection control, wound cleansing, etc.), glycemic control for diabetic foot ulcers, compression therapy for venous stasis ulcers and moist therapy using wound dressing materials.
Key exclusion criteria (6 listed)
- Areas of active infection or latent infection.
- Patients with disorders that would cause an intolerable risk of postoperative complications.
- Ulcers that cannot be sufficiently debrided.
- Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage.
- Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed.
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 |
|---|---|---|
| EPIFIXAlso: DHACMEPIFIX® is an allograft derived from dehydrated human amnion/chorion membrane. EPIFIX is a medical device in Japan (Generic name: Material using human amniotic membrane for promotion of tissue healing) for use on intractable ulcers that are non-responsive to existing therapies for the purpose of promoting wound healing. | Device | Patients with Non-Ischemic Chronic Wounds |
Primary outcome
Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks
Time frame: 4 weeks, 8 weeks, and 12 weeks after initial application
The percentage of patients to achieve wound closure at 4 weeks, 8 weeks, and 12 weeks after initial DHACM application, as a measure of healing rate.
Safety Endpoint: Incidence of Adverse Events
Time frame: 9 months after initial application
Incidence rate of adverse events in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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.
David Mason, MD study director
MiMedx Group, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPIFIX in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by MiMedx Group, Inc. at 5 sites in Japan.
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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Medical Officer (770-651-9100, CTInquiries@mimedx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks (time frame: 4 weeks, 8 weeks, and 12 weeks after initial application). The study lists 2 primary outcomes in all. 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 1 Feb 2024.