A Randomized Post-Market Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating Diabetic Foot Ulcers (DFU) and SanoGraft® in Treating Venous Leg Ulcers (VLU) to SOC Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- 100% epithelialization
研究概览
简要总结
The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome. This information is important to the Centers for Medicare and Medicaid Services (CMS) and other payors in determining coverage policy and reimbursement for this product category.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age
- •Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes
- •Subject's wound is located on foot or ankle (DFU) or leg (VLU)
- •Subject has diabetic foot ulcer > 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer > 1.0 cm2 and ≤ 50 cm2
- •Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great Toe Pressure ≥ 50 mmHg
- •Subject is willing and able to comply with all protocol requirements
- •Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
排除标准
- •Subject is pregnant
- •Subject with diagnosed diabetes has HbA1C > 12 within 3 months Prior to randomization
- •Subject has > 30% reduction in wound size after 2-week run-in period
- •Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
- •Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
- •Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is not excluded if dose < 10 mg per day of prednisone
- •Subject is currently undergoing cancer treatment
- •Subject has used biologic skin substitutes within 14 days of enrollment
- •Subject has an allergy to suture material
- •Subject has life expectancy less than six-months as assessed by the investigator
- •Subject is participating in another clinical research study prior to this study completion
研究组 & 干预措施
Arm 1 PelloGraft
PelloGraft treatment for diabetic foot ulcers versus Standard of Care treatment for diabetic foot ulcers
干预措施: PelloGraft (Other)
Arm 2 SanoGraft
SanoGraft treatment for venous leg ulcers vs Standard of Care treatment for venous leg ulcers
干预措施: SanoGraft (Other)
结局指标
主要结局
100% epithelialization
时间窗: 12 weeks (DFU) or 16 weeks (VLU)
100% epithelialization of wound within 12 weeks (DFU) or 16 weeks (VLU) of initial treatment application. Wound closure is complete with confirmation of 100% epithelialization, no drainage, and no need for additional dressings.
次要结局
- Time to Healing(12 weeks (DFU) or 16 weeks (VLU))