NCT03999281已完成不适用
Retrospective Clinical Trial Study of 188 Consecutive Patients to Examine the Effectiveness of a Biological Active Cryopreserved Human Skin Allograft on the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Primary aim was to determine effectiveness of Theraskin together with standard of care
研究概览
简要总结
Retrospective clinical study of 188 patients to examine effectiveness of human cryopreserved allograft in the treatment of diabetic foot ulcers and venous leg ulcers
详细描述
Retrospective Observational study of 188 consecutive patients to examine the efficacy of biologically active cryopreserved human skin allograft (Theraskin) on the treatment of diabetic foot ulcers and venous leg ulcers
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Theraskin applied to lower extremity wound during the study period.
- •Over 18 years of age.
- •Males and Females.
- •lower Extremity wound due to diabetic neuropathy or venous insufficiency.
- •Documented palpable pedal pulse (dorsalis pedis and/or posterior tibialis arteries and/or palpable bypass graft), or ankle brachial index (ABI) in the range of > 0.8 to < 1.1 or Tcpo2 > 40 mm Hg from the foot at the time of the initial allograft applicaton
- •In subjects with multiple wounds only the largest wound receiving the allograft was included and considered the target wound
- •Initial wound size >1 cm 2
- •All wound locations within the lower extremity (defined as below the knee) and wound durations included
- •Concomitant Negative pressure wound therapy was allowed as this could have been an anchoring technique for the allograft
- •Concomitant antibiotics ( topical, oral, or intravenous) were allowed as it was not possible to determine whether administration of antibiotics was due to a true infection at the target wound site.
排除标准
- •Wound etiologies other than diabetic neuropathy or nevous such as trauma, burns, sickle cell anemia, necrobiosis lipoidica , pyoderma gangrenosum.
- •Wound not present for at least 30 days and showing lack of progression for at least 30 days prior to application of Theraskin.
- •Other ulcer treatments besides study allograft during the study period ( study period definition: time of first allograft application up to 20 weeks) were not included in this study. These concomitant treatments specifically include hyperbaric oxygen treatments, venous ablation procedures, revascularization procedures including lower extremity bypass grafts or angioplasties or stents, application of additional growth factors, biologic products containing cells or other tissue-derived products, matrix components, or enzymatic debriders. Subjects were allowed to receive standard of care therapy with the study allograft, which included debridement, moist dressings or compression dressings depending on wound etiology, and off-weighting depending on wound location.
- •Patients with revascularization procedures (defined as lower extremity bypass grafts, angioplasties, or stents) within 30 days of initial TheraSkin application were excluded
- •Patients with successful surgical correction or intervention aimed at improving venous return in the target limb, such as venous ablation procedures, within 30 days of initial TheraSkin application were excluded
结局指标
主要结局
Primary aim was to determine effectiveness of Theraskin together with standard of care
时间窗: 12-20 weeks
Theraskin used together with standard of care in healing DFU and VLU wounds
次要结局
- Measure of effectiveness based on healing(12-20 weeks)
研究者
研究点 (1)
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