A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix for the Treatment of Diabetic Foot Ulcers (DFU)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 主要终点
- To determine the efficacy of Dermacyte Matrix compared to SOC based on total wound closure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •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
排除标准
- •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:
- •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
结局指标
主要结局
To determine the efficacy of Dermacyte Matrix compared to SOC based on total wound closure
时间窗: 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.
次要结局
- To determine the safety of Dermacyte Matrix compared to SOC(12 weeks)
- To determine the heal rate of DFU for Dermacyte Matrix and SOC(12 weeks)