A Retrospective Record-review Study in Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Demographic Characteristics: Weight (Mean)
研究概览
简要总结
The purpose of the study is to evaluate the medical cost of illness for DFUs on the patients who had used ON101 or Aquacel® in the ON101CLCT02 trial.
详细描述
This ClinicalTrials.gov record exists that reports results for the ON101CLCT02 trial.(identifier: NCT01898923)
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No additional inclusion or
排除标准
- •will be applied.
研究组 & 干预措施
ON101 Cream
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm
干预措施: ON101 Cream (Drug)
Aquacel® Hydrofiber® dressing
Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm
结局指标
主要结局
Demographic Characteristics: Weight (Mean)
时间窗: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Demographic Characteristics: BP (Mean)
时间窗: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Demographic Characteristics: ABI (Mean)
时间窗: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease. An index higher than 1.3 indicates stiff, non-compressible blood vessels which are common in diabetes. Left and right Ankle-Brachial Index (ABI) values are calculated by dividing the highest systolic pressure from each ankle (posterior tibial or dorsalis pedis artery) by the highest overall brachial (arm) systolic pressure.
Medical Costs Due to DFUs
时间窗: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
The total medical cost due to diabetic foot ulcers across 140 participants is reported.
Percentage of Amputation
时间窗: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.
Major amputations involve removing a limb above or through the ankle (e.g., below-knee/transtibial, above-knee/transfemoral), significantly impacting mobility. Minor amputations, such as toes or metatarsal, are distal to the ankle and aim to preserve function. Total amputations include the sum of major and minor amputations.
次要结局
未报告次要终点