NCT02248077撤回4 期
A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Cytomedix
- 主要终点
- Complete Ulcer Closure
研究概览
简要总结
This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).
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
- •For DFU indication:
- •Medicare beneficiary
- •Males or females ≥ 18 years of age
- •Type I or II diabetes requiring medical treatment as determined by the physician
- •The single wound to be applied Study Treatment (Index Ulcer) is a Wagner 1-4 DFU (see Section 17.12 Appendix 12 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot (including all toe surfaces and the heel)
- •Patients have been treated with UCC at the center for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
- •For patients with multiple potential Index DFUs, the largest ulcer will be selected. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the patient should not be enrolled (screen failure)
- •Demonstrated offloading regimen
- •A wound age of ≥ 30 days at the Screening Visit
- •Patient must be willing to comply with the protocol, which will be assessed by enrolling clinician.
- •Patient must sign an Informed Consent Form prior to any study-related procedures.
- •For VLU indication:
- •Medicare beneficiary
- •Males or females ≥ 18 years of age
- •Diagnosed venous disease
- •Patients have been seen at the center/site for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
- •The non-healing wound is located between the knee and ankle and may include ankle
- •For patients with multiple potential Index VLUs, the largest ulcer will be selected. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the patient should not be enrolled (screen failure)
- •Demonstrated compression regimen
- •A wound age of ≥ 30 days at the Screening visit
- •Patient must be willing to comply with the protocol, which will be assessed by enrolling clinician
- •Patient must sign an Informed Consent prior to any study-related procedures.
- •For PU indication:
- •Medicare beneficiary
- •Males or females ≥ 18 years of age
- •Ulcer of pressure/shear etiology (Stage II, III, IV, see Section 17.13 Appendix 13 for stage definitions)
- •Patients have been seen at the site for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
- •The single wound to be applied Study Treatment (Index Ulcer) that is located on the heel, ischium, sacrum, coccyx or trochanter
- •For patients with multiple potential PUs, the largest ulcer will be selected. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the patient should not be enrolled (screen failure)
- •Demonstrated pressure relief regimen
- •A wound age of ≥ 30 days at Screening visit
- •Patient must be willing to comply with the Protocol, which will be assessed by enrolling clinician.
- •Patient must sign an Informed Consent prior to any study-related procedures.
排除标准
- •Patients known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
- •Presence of another wound that is concurrently treated and might interfere with the treatment of the Index wound
- •Malignancy in wound bed
- •Active clinical wound infection.
- •Patient has inadequate venous access for repeated blood draw required for AutoloGel processing
- •Patients who are cognitively impaired and do not have a healthcare proxy
结局指标
主要结局
Complete Ulcer Closure
时间窗: 12 weeks
Proportion of patients with complete ulcer closure
次要结局
未报告次要终点
研究者
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