Diabetic Foot UlcerNCT06444906
A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix
A study testing Dermacyte Matrix in people with Diabetic Foot Ulcer, run by Merakris Therapeutics.
Trial summary
This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or SOC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Dermacyte Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 May 2025
- Phase
- Interventional
- 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
Who may be able to join
- Participant 18 years old or older
- Type I or Type II diabetes mellitus
- Participant has well controlled glucose levels, with HbA1c < 12% within 3 months of Dermacyte Matrix application
- Participant has adequate lower extremity perfusion, with Ankle-Brachial Index > 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high Ankle-Brachial Indices.) or dorsum transcutaneous oxygen test (TcPO2) > 30 mmHg. The presence of tibial and plantar pulses is preferred.
- Willing and able to tolerate and maintain the required weight off-loading of the affected limb and perform necessary dressing changes
- DFU is full thickness (Wagner Grade I or II)
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- Adults with a chronic non-healing DFU (at least 30 days but no longer than 52 weeks old) will be eligible for enrollment
- Participant's ulcer size >0.5cm2 and < 20cm2 area post-debridement
- Participant has plantar ulcers of greater than or equal to 4 weeks duration at presentation, unresponsive to standard wound care
- Participant should have no evidence of unresolved gross soft-tissue infection or boney pathology (i.e. osteomyelitis)
- Participant should have no evidence of underlying co-morbid conditions that would adversely affect wound healing such as: Cancer, Raynaud's syndrome, severe venous insufficiency or uncorrected arterial insufficiency, etc.
- Participant should not be on medications that compromise healing: cytotoxic chemotherapeutics, etc
Who cannot join
- Suspected or confirmed signs of infection of the study ulcer/limb including soft-tissue infection or osteomyelitis
- Subjects who are currently receiving, or have received within 4 weeks prior to study entry agents known to impair or affect wound healing, including:
- Adriamycin (doxorubicin), bleomycin, sirolimus (Rapamune, rapamycin) and anti-TNF cytotoxic/immunosuppressive agents;
- Radiation therapy at the ulcer site;
- Other immunosuppressive agents.
- Subjects presenting with:
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- Charcot foot with a bony deformity
- Chopart's amputation
- Calcaneus ulcers
- Subjects previously treated with amniotic membrane or any other advanced therapy at the target site for 1 month prior to enrollment
- Subjects with evidence of skin cancer within or adjacent to the ulcer site.
- History of bone cancer of the affected limb
- Subjects who have significant arterial disease as determined by ABI, duplex Doppler sonography (PVR) or magnetic resonance angiography (MRA): Ankle-Brachial Index < 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high ABIs); dorsum transcutaneous oxygen test (TcPO2) < 30 mmHg; absence of tibial or plantar pulses.
- Subjects who have documented clinically significant medical conditions, which would impair wound healing. This includes:
- Renal impairment (creatinine >2.5 mg/dL);
- Hepatic impairment (2XULN);
- Hematological disorders (abnormities of formed elements);
- Neurologic disorders resulting in significant impairment of sensory and motor functions as judged by the investigator;
- Excessive lymphedema that could interfere with wound healing
- Subjects with signs and symptoms of cellulitis;
- Subjects with ulcers with sinus tracts associated with an ongoing infection;
- Subjects with active deep vein thrombosis;
- Subjects with uncontrolled diabetes, as demonstrated by increased HbA1C (> 12%);
- Immunocompromised subjects (e.g., lymphoma, AIDS, myelodysplastic disorders)
- HBOT within 3 days of treatment visit
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix for the Treatment of Diabetic Foot Ulcers (DFU)
This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or SOC.
Read the detailed description
This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or standard of care (SOC).
Part 1 of the study will enroll 20 participants to determine the percentage of participants with a complete ulcer closure following treatment with Dermacyte Matrix at Week 12.
In Part 2 of the study approximately 65 participants will be randomized 1:1 to receive Dermacyte Matrix or SOC for 12 weeks. The final sample size for Part 2 may be adjusted based on the effect size observed in Part 1 of the study.
For the purposes of this study, SOC therapy will consist of debridement of nonviable tissue, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Dermacyte Matrix, Standard of Care (SOC)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermacyte MatrixDevice
The appropriate square centimeters of Dermacyte Matrix is applied directly to the target DFU that is free of debris and necrotic tissue. The Dermacyte Matrix will be applied at weekly intervals or for up to 10 applications.
Standard of Care (SOC)Other
SOC therapy will consist of debridement of nonviable tissue, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated at weekly intervals or for up to 10 applications.
| Study group | Role | What they receive |
|---|---|---|
| Dermacyte Matrix | Active comparator | Dermacyte Matrix will be applied topically in conjunction with SOC on a weekly frequency and dosed by square centimeters to match the ulcer surface area. Receives: Device: Dermacyte Matrix |
| Standard of Care | Other | SOC therapy will consist of weekly debridement of nonviable tissue as clinically indicated, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of Dermacyte Matrix compared to SOC based on total wound closure
Wound healing will be assessed by observation of skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits at least 2 weeks apart.
Measured: 12 weeks
Secondary outcomes (2)
To determine the safety of Dermacyte Matrix compared to SOC
Safety will be assessed throughout the study. Adverse events will be recorded using the NCI Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5).
Measured: 12 weeks
To determine the heal rate of DFU for Dermacyte Matrix and SOC
Healing rate will be assessed by percent area reduction of the target ulcer from Baseline to Week 12.
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 posted6 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merakris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean O'Connell, PhD, Study director, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444906
- Sponsor's protocol ID
- DM-DFU-201
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- 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 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix for the Treatment of Diabetic Foot Ulcers (DFU)
- ClinicalTrials.gov ID
- NCT06444906
- Acronym / sponsor ID
- DM-DFU-201
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Merakris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 6 Jun 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 is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or SOC.
Detailed description
This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or standard of care (SOC).
Part 1 of the study will enroll 20 participants to determine the percentage of participants with a complete ulcer closure following treatment with Dermacyte Matrix at Week 12.
In Part 2 of the study approximately 65 participants will be randomized 1:1 to receive Dermacyte Matrix or SOC for 12 weeks. The final sample size for Part 2 may be adjusted based on the effect size observed in Part 1 of the study.
For the purposes of this study, SOC therapy will consist of debridement of nonviable tissue, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermacyte Matrix | Active comparator | Device: Dermacyte MatrixDermacyte Matrix will be applied topically in conjunction with SOC on a weekly frequency and dosed by square centimeters to match the ulcer surface area. |
| Standard of Care | Other | Other: Standard of Care (SOC)SOC therapy will consist of weekly debridement of nonviable tissue as clinically indicated, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant 18 years old or older
- Type I or Type II diabetes mellitus
- Participant has well controlled glucose levels, with HbA1c < 12% within 3 months of Dermacyte Matrix application
- Participant has adequate lower extremity perfusion, with Ankle-Brachial Index > 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high Ankle-Brachial Indices.) or dorsum transcutaneous oxygen test (TcPO2) > 30 mmHg. The presence of tibial and plantar pulses is preferred.
- Willing and able to tolerate and maintain the required weight off-loading of the affected limb and perform necessary dressing changes
Key exclusion criteria (25 listed)
- Suspected or confirmed signs of infection of the study ulcer/limb including soft-tissue infection or osteomyelitis
- Subjects who are currently receiving, or have received within 4 weeks prior to study entry agents known to impair or affect wound healing, including:
- Subjects presenting with:
- Subjects previously treated with amniotic membrane or any other advanced therapy at the target site for 1 month prior to enrollment
- Subjects with evidence of skin cancer within or adjacent to the ulcer site.
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 |
|---|---|---|
| Dermacyte MatrixThe appropriate square centimeters of Dermacyte Matrix is applied directly to the target DFU that is free of debris and necrotic tissue. The Dermacyte Matrix will be applied at weekly intervals or for up to 10 applications. | Device | Dermacyte Matrix |
| Standard of Care (SOC)SOC therapy will consist of debridement of nonviable tissue, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated at weekly intervals or for up to 10 applications. | Other | Standard of Care |
Primary outcome
To determine the efficacy of Dermacyte Matrix compared to SOC based on total wound closure
Time frame: 12 weeks
Wound healing will be assessed by observation of skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits at least 2 weeks apart.
2 secondary outcomes
To determine the safety of Dermacyte Matrix compared to SOC
Time frame: 12 weeks
To determine the heal rate of DFU for Dermacyte Matrix and SOC
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- 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.
Sean O'Connell, PhD study director
Consultant
Questions about this trial
What is this clinical trial studying?
A study testing Dermacyte Matrix in people with Diabetic Foot Ulcer, run by Merakris Therapeutics.
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 12 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Travis C Jarrell, MS (301-905-6702, tcjarrell@milestoneregualtory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of Dermacyte Matrix compared to SOC based on total wound closure (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 10 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.