DRKS00010236已完成不适用
Application of HydroTac® for venous leg ulcer wound healing - BOOST-CLOSURE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1) Patient is minimum 18 years of age and has given formal written consent.
- •2) Patient suffers from Ulcus cruris venosum.
- •3) Size of ulcera is between 5cm2 and 50cm2.
- •4) Ulcera persists since min. 3 and max. 36 months and was treated/seen by a physician.
- •5) Wound surface is covered by vital granulation tissue to a minimum of 50% (can be also achieved by debridement).
- •6) Patient is treated by compression therapy and is willing to the usage of compression therapy (socks/ bandages) for study duration.
- •7) Compression therapy is subscribed. Patient has no arterial circulatory disorder with an ankle-brachial pressure index < 0.8 or a missing pedal pulse.
排除标准
- •1) Patient suffers from Ulcus cruris venosum with signs of infection which is treated by antibiotics.
- •2) Known allergy or intolerance to the study product.
- •3) Wound has an area with black, necrotic, non-vital tissue or ABI <0.8 or pedal pulse missing.
- •4) According to physician’s assessment, patient’s general condition does not allow or makes it unlikely to take part in treatment duration for 8 weeks.
- •5) Wound was caused by malign illness (also if venous insufficiency is main cause).
- •6) Patient suffers from diabetes mellitus with is not adequate adjusted (HbA1c >70 mmol/mol).
- •7) Patient suffers from severe dysfunction of liver or kidney and/ or is kidney dialysis obligatory.
- •8) Patient suffers from active autoimmune disorder and is treated with corticosteroid (>10 mg prednisolone equivalent/day) and/or immunosuppressive and/ or chemotherapy.
- •9) According to physicians assessment, patient is not able to follow study protocol (e.g. due to cognitive disease) or is not able to understand state, nature, meaning and consequences of the study.
- •10) Patient is not willing or able to apply adequate compression therapy.
- •11) In addition to study product, further products in direct contact to wound surface will be used.
- •12) The study-relevant wound was already treated with HydroTac® during the last four weeks before study start.
- •13) Participation in this study or any other study in the last four weeks before beginning of study.
- •Only for female patients:
- •14) Patient is pregnant or breast-feeding.
研究者
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