ISRCTN90301130已完成不适用
Treatment of Diabetic Foot Wounds by Vacuum-Assisted Closure (VAC®): A multicentre, randomised controlled trial
Private University of Witten/Herdecke gGmbH (Germany)0 个研究点目标入组 300 人开始时间: 2010年7月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Evidence of diabetes mellitus type I, II or III as defined by the necessity for antidiabetic drugs for = 12 months
- •2. All wounds corresponded to University of Texas grade 2 or 3 in depth
- •2.1. either a chronic wound which is planned to receive radical surgical debridement
- •2.2. or an amputational wound which results from a planned below-ankle amputation
- •3. Participant has given written informed consent
排除标准
- •1. Pregnancy
- •2. Age <18 years
- •3. Missing Compliance
- •4. Untreated or refractory phlegmona or untreated osteomyelitis of the wound
- •5. Exposed blood vessels in or around the wound that can't be protected or have a heightened risk for a bleeding with relevant circulation effects
- •6. Any revascularization procedure or amputation of the same extremity within the last 5 days
- •7. Indication for above-ankle amputation of the same extremity
- •8. Any extreme defective position of toes, foot or the whole extremity which could lead to ischemia of the wound area and impair wound healing
- •9. Evidence of inadequate perfusion
- •9.1. via MR angiography within the last 3 month or
- •9.2. sonographic confirmation of absence of peripheral pulse at A. tibialis posterior or A. dorsalis pedis) or
- •9.3. transcutaneous oxygen measurements of the dorsum of the foot =30 mmHg or
- •9.4. ankle brachial indices =0,7 and =1.2 and toe pressure at =30 mmHg
- •10. Renal insufficiency with need for dialysis
- •11. Anemia which is not caused infection
- •12. Long term use of oral (p.o.) steroids (> 30days)
- •13. Chronic anticoagulation except acetylsalicylate, clopidogrel (e.g. by vitamin K an-tagonists) at screening that can't be bridged to heparins during participation in the trial
- •14. Nerve lesions or active Charcot disease (Diabetic neuro-osteoarthropathy) of either lower extremity that will interfere with wound treatment
- •15. Malignancy in the wound or the periwound area or any other malignancy requiring immunosuppressant therapy or chemotherapy
- •16. Wounds resulting from burns, untreated cellulitis or collagen vascular disease
- •17. Presence of necrotic tissue that cannot be debrided
- •18. Concomitant severe skin disease that may impair wound healing
- •19. Connective tissue disease that might impair wound healing
- •20. Hematological disorders or condition that might impair wound healing
- •21. History of significant chronic anemia as evidenced by hemoglobin concentration of < 10 g/dl within 30 days of screening
- •22. Any kind of chronic venous insufficiency (CVI) or CVI that leads to varicose eczema, lo-cal inflammation and an increased risk of ulcers
- •23. Use of VAC® negative pressure wound therapy (NPWT) or any other suction device system on the study wound = 8 days prior to screening
- •24. Previous treatment with hyperbaric oxygen therapy (HBO) or normothermic therapy in the past 8 days
- •25. Application of recombinant or autologous growth factors on the study wound = 8 days prior to screening
- •26. Application of skin or dermal substitutes and dressings with living cells capable of producing growth factors (e.g. Oasis®, Apligraf®, Dermagraft™, or Integra®) on the study extremity < 15 days prior to screening
- •27. Allergy to any disposal component of the VAC® or MWT used materials
- •28. Simultaneous participation in other interventional trials interfering with one of the approaches in this trial
- •29. Previous participation in this trial
研究者
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