A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix

Launched by MERAKRIS THERAPEUTICS · May 30, 2024

Keywords

ClinConnect 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 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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant 18 years old or older
• • 2. Type I or Type II diabetes mellitus
• • 3. Participant has well controlled glucose levels, with HbA1c \< 12% within 3 months of Dermacyte Matrix application
• • 4. 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.
• • 5. Willing and able to tolerate and maintain the required weight off-loading of the affected limb and perform necessary dressing changes
• • 6. DFU is full thickness (Wagner Grade I or II)
• • 7. Adults with a chronic non-healing DFU (at least 30 days but no longer than 52 weeks old) will be eligible for enrollment
• • 8. Participant's ulcer size \>0.5cm2 and \< 20cm2 area post-debridement
• • 9. Participant has plantar ulcers of greater than or equal to 4 weeks duration at presentation, unresponsive to standard wound care
• • 10. Participant should have no evidence of unresolved gross soft-tissue infection or boney pathology (i.e. osteomyelitis)
• • 11. 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.
• • 12. Participant should not be on medications that compromise healing: cytotoxic chemotherapeutics, etc
• Exclusion Criteria:
• • 1. Suspected or confirmed signs of infection of the study ulcer/limb including soft-tissue infection or osteomyelitis
• 2. Subjects who are currently receiving, or have received within 4 weeks prior to study entry agents known to impair or affect wound healing, including:
• • 1. Adriamycin (doxorubicin), bleomycin, sirolimus (Rapamune, rapamycin) and anti-TNF cytotoxic/immunosuppressive agents;
• • 2. Radiation therapy at the ulcer site;
• • 3. Other immunosuppressive agents.
• 3. Subjects presenting with:
• • 1. Charcot foot with a bony deformity
• • 2. Chopart's amputation
• • 3. Calcaneus ulcers
• • 4. Subjects previously treated with amniotic membrane or any other advanced therapy at the target site for 1 month prior to enrollment
• • 5. Subjects with evidence of skin cancer within or adjacent to the ulcer site.
• • 6. History of bone cancer of the affected limb
• • 7. 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.
• 8. Subjects who have documented clinically significant medical conditions, which would impair wound healing. This includes:
• • 1. Renal impairment (creatinine \>2.5 mg/dL);
• • 2. Hepatic impairment (2XULN);
• • 3. Hematological disorders (abnormities of formed elements);
• • 4. Neurologic disorders resulting in significant impairment of sensory and motor functions as judged by the investigator;
• • 5. Excessive lymphedema that could interfere with wound healing
• • 6. Subjects with signs and symptoms of cellulitis;
• • 7. Subjects with ulcers with sinus tracts associated with an ongoing infection;
• • 8. Subjects with active deep vein thrombosis;
• • 9. Subjects with uncontrolled diabetes, as demonstrated by increased HbA1C (\> 12%);
• • 10. Immunocompromised subjects (e.g., lymphoma, AIDS, myelodysplastic disorders)
• • 9. HBOT within 3 days of treatment visit

Trial Officials