Trial document




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  DRKS00003347

Trial Description

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Title

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
A study project with a pragmatic approach to evaluate the negative pressure wound therapy in the medical treatment sectors in Germany

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Trial Acronym

DiaFu

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URL of the Trial

http://www.wound-care.de

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Brief Summary in Lay Language

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. The background to this research project is the decision of the Federal Joint Committee, which states that the negative pressure wound therapy can`t be accepted as a standard therapy with complete performance of the health insurance reimbursement. This decision is based on the reports of the Institute for Quality and Efficiency in Health Care about already existing study projects, which showed a lack of evidence regarding the use of this form of therapy for the treatment of acute and chronic wounds.
This study will be performed in several hospitals in Germany. The study is due to evaluate whether the negative pressure wound therapy or the control therapy (standard wound therapy following the guidelines) is superior with respect to the target values.
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.
The target values of the investigation are clinical, safety and economic indicators.
The two primary outcome measures are the achievement of a complete wound closure and the time required to achieve this within a treatment period of 16 weeks.
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.
Due to the results of already existing clinical studies and the experience from the clinical application 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. Furthermore, it is believed 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 2014 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.

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Brief Summary in Scientific Language

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. All used treatment systems bear the CE mark and will be used within normal conditions of clinical routine and according to manufacturer's instructions.
This research project is performed because of a decision of the Federal Joint Committee Germany, which states that negative pressure wound therapy can´t be accepted as a standard therapy with full reimbursement by the health insurance companies in Germany. This decision is based on the rapid report and the final report of the Institute for Quality and Efficiency in Health Care, which showed through systematic reviews and meta-analysis of previous study projects that an insufficient state evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds is existing.
This study evaluates the treatment outcome of the application of a technical medical device, which is based on the principle of negative pressure wound therapy (treatment group 1: Intervention Group) in comparison to standard wound therapy (treatment group 2: Control group) in the treatment of chronic foot wounds after adequate (debridement of avital tissue) wound preparation or amputation wounds resulting from a scheduled amputation below the ankle (Latin. talocruralis articulation), which are caused in the context of a diabetic foot syndrom.
The clinical trial is designed as a national, multicenter, prospective, randomized controlled superiority study. A blinded evaluation of wound photographs will be performed.
Patients will be randomized 1:1 to the treatment arm: negative pressure wound therapy and the control arm: standard wound therapy.
Patients will be stratified according to assignment to the participating institution (hospital) and by Wagner-Armstrong Stadium.
The inclusion and exclusion criteria are based on the presence of a diagnosis of a diabetic foot wound, the regulatory requirements to the participants in a clinical study and the examination and treatment according to current treatment regulations, evidence-based guidelines and the specifications of the manufacturers of the medical devices.
Only patients meeting all inclusion criteria and no exclusion criterion are allowed to be included into the trial.
The aim of this study is to compare the clinical, safety and economic results of both treatment arms.
The primary endpoints to evaluate the efficacy of negative pressure wound therapy in the treatment of chronic foot wounds caused by a diabetic foot syndrome are both the number of complete wound closure within the maximum treatment period (measured in days) as well as the time until complete wound closure. Complete wound closure should be achieved within the maximum study treatment period of 16 weeks.
In addition, secondary clinical endpoints and safety endpoints, patient-reported outcome endpoints and health economic endpoints are evaluated.
The clinical examination includes parameters that can be used for the analysis of resource use in the inpatient and outpatient care. This includes a comparative analysis of parameters of direct and indirect resource use.
Primarily the perspective of the Statutory Health Insurance is considered. As a secondary perspective the view of society was selected.
Sample size calculation was performed considering results of existing trials, which revealed that a number n = 324 patients must be included in the study in order to carry out the analysis of the primary endpoint "Closure rate".
In due consideration of screening failures, discontinuation of therapy of any cause and losses to Follow-Up a screening of a total of 464 patients must be performed to provide the calculated sample size.The primary efficacy analysis is performed using the intention-to-treat group.
Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors.

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Organizational Data

  •   DRKS00003347
  •   2011/11/22
  •   [---]*
  •   yes
  •   Approved
  •   97/2011, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1125-9104 
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Health Condition or Problem studied

  •   Chronic diabetic foot wounds after debridement avital tissue components
  •   Chronic diabetic foot wounds after amputation below the articulatio talocruralis
  •   E10.74 -  [generalization E10.7: Insulin-dependent diabetes mellitus; With multiple complications]
  •   E10.75 -  [generalization E10.7: Insulin-dependent diabetes mellitus; With multiple complications]
  •   E11.74 -  [generalization E11.7: Non-insulin-dependent diabetes mellitus; With multiple complications]
  •   E11.75 -  [generalization E11.7: Non-insulin-dependent diabetes mellitus; With multiple complications]
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Interventions/Observational Groups

  •   Negative Pressure Wound Therapy
  •   Standard wound therapy according to current evidence-based guideline
    (basic and advanced methods of wound treatment)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Number of achieved and confirmed wound closures within a maximum treatment time of 16 weeks plus the time until complete wound closure (in days)
The 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.
The closure must remain at least for a period of 14 days.

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Secondary Outcome

Time until optimal preparation of the wound bed for further therapy (granulation of at least 95%);
Time to reach a complete wound closure within the observation period of 6 months;
Recurrences; Amputations (appearance and dimension); Wound size over time;
Proportion of wound tissue qualities over time; all SAEs within 6 months; wound specific and device specific AEs within the active study treatment time of 16 weeks or until end of therapy; Pain (NRS) within the active study treatment time of 16 weeks or until end of therapy; Quality of Life (EQ-5D) within 6 months; direct costs (medical and non-medical); indirect costs

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • other 
  • Medical Center 
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Recruitment

  •   Actual
  •   2011/12/23
  •   464
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Presence of diabetes mellitus; Presence of a foot wound (chronic wounds; amputational 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

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Exclusion Criteria

Age <18 years; Pregnancy; Non-Compliance; Allergies regarding the release of substances from components of each treatment arm; Severe anemia, which 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 inclusio; 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

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Addresses

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    • Private Universität Witten / Herdecke gGmbH
    • Ms.  Dörthe  Seidel 
    • Alfred-Herrhausen-Straße 50
    • 58448   Witten
    • Germany
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    • Institut für Forschung in der Operativen Medizin Private Universität Witten/Herdecke gGmbH
    • Ms.  Dörthe  Seidel 
    • Ostmerheimer Straße 200
    • 51109  Köln
    • Germany
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    • Institut für Forschung in der Operativen Medizin Private Universität Witten/Herdecke gGmbH
    • Ms.  Dörthe  Seidel 
    • Ostmerheimerstraße 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • KCI Medizinprodukte GmbH
    • Hagenauer Str. 47
    • 65203  Wiesbaden
    • Germany
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  • start of 1:1-Block address otherSupport
    • Smith & Nephew GmbHAbteilung Wound Management
    • Osterbrooksweg 71
    • 22869   Schenefeld
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/04/17
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.