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

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.

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.

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