Randomized, Controlled Clinical Trial Evaluating the Efficacy and Clinical Effectiveness of Negative Pressure Wound Therapy for the Treatment of Diabetic Foot Wounds When Compared to Standard Wound Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 84
- 主要终点
- Number of achieved and confirmed wound closures within the maximum study treatment time
研究概览
简要总结
On behalf of a consortium of 19 health insurance companies the Institute for Research in Operative Medicine as part of the University of Witten / Herdecke gGmbH is planning and conducting a clinical study evaluating the efficacy and effectiveness of negative pressure wound therapy in the treatment of wound healing disorders of the foot, which are caused by diabetes mellitus.
This german multicenter study is due to evaluate whether the negative pressure wound therapy or the control therapy (standard wound therapy following the guidelines) is superior.
Patients will be randomly assigned to the two study arms. Both patients and the treatment staff know about the specific allocation to the negative pressure wound therapy or standard wound therapy arm.
A photo documentation and a computer-based evaluation of the wound images will be performed. This is done centrally by independent examiners, who don't know neither the patient nor the treatment assignment.
It is believed that the application of the negative pressure wound therapy systems compared to standard therapy of diabetic foot wounds will lead more frequent and more rapid to the achievement of complete wound closure and that the use of negative pressure wound therapy is an effective and safe therapy option for the treatment of diabetic foot wounds in inpatient and outpatient care.
Patient´s to be included into the study should have either a chronic diabetic foot wound existing longer than 4 weeks whereas dead tissue components must be completely removed by the doctor or a wound after amputation of foot parts.
The study treatment may have already started in the hospital if applicable. The further wound treatment will be mainly performed within outpatient care. Study Participants will return to the study centre for regular study visits or even for wound treatment.
The comparison of the outcomes of both study arms will give valuable information about the efficacy of negative pressure wound therapy in inpatient as well as outpatient care. These results should be provided until the end of 2016 as a basis for the decision of the Federal Joint Committee to answer the question if the negative pressure wound therapy can be approved as a standard service for reimbursement by health insurance companies.
详细描述
This study project as part of a European tender has the aim to prove efficacy and effectiveness of negative pressure wound therapy in the management of patients with chronic diabetic foot wounds. The tasks within the study project have been assigned to three contractors / institutions.
On behalf of a consortium of 19 health insurance companies with a central contact consisting of the "AOK-Bundesverband GbR", "Verband der Ersatzkassen e.V." (vdek) and the "Knappschaft" these contractors are responsible for conducting the trial.
The Institute for Research in Operative Medicine (IFOM) as part of the University of Witten / Herdecke gGmbH is responsible for the planning, implementation, analysis and publication of the study.
The Private University of Witten / Herdecke takes over the sponsorship of the study project. The duties and responsibilities of the sponsor are transferred to the staff of the Institute for Research in Operative Medicine of University of Witten / Herdecke. The financial support of the clinical study is provided by the manufacturers of the negative pressure wound therapy systems. The task of payment processing and the contractual provisions is taken over by a management company "Gesundheitsforen Leipzig".
Therapy systems used within the treatment arm of the study will be provided by two manufacturers Kinetic Concepts Incorporated (KCI) and Smith & Nephew Inc. All used treatment systems bear the CE mark and will be used within normal conditions of clinical routine and according to manufacturer's instructions.
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
- Single (Outcomes Assessor)
盲法说明
Wound photographs are analysed by blinded outcome assessors
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
- •Presence of diabetes mellitus
- •Presence of a foot wound (chronic wounds; amputation wounds) Wagner stage 2-4
- •Existence of the foot wound for at least 4 weeks
- •Signed informed consent form
- •Patient's eligibility of NPWT in the opinion of the treating physician
排除标准
- •Age <18 years
- •Non-Compliance
- •Pregnancy
- •Allergies regarding the release of substances from components of each treatment arm
- •Severe anemia, wich was not caused by an infection
- •Simultaneous participation of patients in another interventional study / previous participation in the same study
- •Use of NPWT systems to the study-related foot lesion within a period of 6 weeks prior to study inclusion
- •Presence of necrotic tissue with eschar, which can not be removed
- •Untreated osteitis or osteomyelitis
- •Not examined / unexplored fistula
- •Malignancy of the wound
- •Exposed: nerves, blood vessels, anastomotic site
- •ambulant NPWT of patients receiving anticoagulants (especially heparinization or marcumar therapy) or with otherwise highly impaired clotting function, which have a risk of circulatory relevant bleeding
结局指标
主要结局
Number of achieved and confirmed wound closures within the maximum study treatment time
时间窗: 16 weeks
Complete wound closure is defined as 100% epithelialization; no need for drainage, no need for supportive therapy or a means of assistance and absence of suture material. Wound closure must sustain at least for a period of 14 days and needs to be confirmed within a separate study visit 14 days after the first diagnosis of wound closure.
Time until wound closure within the maximum study treatment time
时间窗: 16 weeks
Complete wound closure is defined as 100% epithelialization; no need for drainage, no need for supportive therapy or a means of assistance and absence of suture material. Wound closure must sustain at least for a period of 14 days and needs to be confirmed within a separate study visit 14 days after the first diagnosis of wound closure.
次要结局
- Wound size(16 weeks)
- Time until optimal wound bed preparation(16 weeks)
- Time until wound closure within the observation period(6 months)
- Recurrences(6 months)
- Amputations(16 weeks)
- Wound tissue qualities(16 weeks)
- Wound-related pain (Numeric Rating Scale)(16 weeks)
- Quality of Life questionaire (EQ-5D)(6 months)
- Indirect costs(within a maximum treatment time of 16 weeks or until end of therapy)
- Number of complete wound closures within the observation period(6 months)
- Direct costs(within a maximum treatment time of 16 weeks or until end of therapy)
- Adverse Events(16 weeks)
- Serious adverse events(6 months)
研究者
Doerthe Seidel
Head of division for clinical research at the Institute for Research in Operative Medicine
University of Witten/Herdecke