Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds (DiaFu)

This study is currently recruiting participants.
Verified October 2012 by University of Witten/Herdecke
Sponsor:
Collaborators:
Kinetic Concepts, Inc.
Smith & Nephew Wound Management Inc
Information provided by (Responsible Party):
Doerthe Seidel, University of Witten/Herdecke
ClinicalTrials.gov Identifier:
NCT01480362
First received: November 23, 2011
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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 6 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.


Condition Intervention
Foot Ulcer, Diabetic
Device: Negative Pressure Wound Therapy
Other: Standard Wound Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Witten/Herdecke:

Primary Outcome Measures:
  • Wound Closure [ Time Frame: within a maximum treatment time of 16 weeks ] [ Designated as safety issue: No ]

    Number of achieved and confirmed wound closures 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.



Secondary Outcome Measures:
  • Time until optimal wound bed preparation [ Time Frame: within a maximum treatment time of 16 weeks ] [ Designated as safety issue: No ]
    Time until optimal preparation of the wound bed for further therapy (granulation of at least 95%)

  • Time until complete wound closure [ Time Frame: within 12 months ] [ Designated as safety issue: No ]
    Time to reach a complete wound closure within the observation period of 12 months

  • Recurrences [ Time Frame: within the observation period of 12 months ] [ Designated as safety issue: No ]
    Recurrences within the observation period of 12 months after complete and confirmed wound closure

  • Amputations [ Time Frame: within a maximum treatment time of 16 weeks and within the observation period of 12 months ] [ Designated as safety issue: Yes ]
    Appearance and dimension of amputations

  • Wound size [ Time Frame: within a maximum treatment time of 16 weeks ] [ Designated as safety issue: No ]
    Wound size over time

  • Wound tissue qualities [ Time Frame: within a maximum treatment time of 16 weeks ] [ Designated as safety issue: No ]
    Proportion of wound tissue qualities over time

  • Number of complete wound closures [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
  • Number of complete wound closures [ Time Frame: within 12 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: within a maximum treatment time of 16 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: within the observation period of 12 months ] [ Designated as safety issue: No ]
    EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 12 months

  • Direct costs [ Time Frame: within a maximum treatment time of 16 weeks or until end of therapy ] [ Designated as safety issue: No ]
    direct medical resource use and costs: hospitalization, outpatient contact with study centre and other providers, reimbursable drugs, medical sundries, adjuvants, reimbursable services direct non-medical resource use and costs: services, travel costs, expenditure of time for patients, expenditure of time for lay care

  • Indirect costs [ Time Frame: within a maximum treatment time of 16 weeks or until end of therapy ] [ Designated as safety issue: No ]
    disability, disability pension, premature death

  • Serious adverse events [ Time Frame: within the observation period of 12 months ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: within a maximum treatment time of 16 weeks ] [ Designated as safety issue: Yes ]
    wound specific and device specific adverse events


Estimated Enrollment: 464
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Negative Pressure Wound Therapy Device: Negative Pressure Wound Therapy

Used therapy systems:

KCI. V.A.C. Freedom; Acti V.A.C.; INFO V.A.C. to be used with the V.A.C. Granufoam (black), V.A.C. Granufoam Silver and V.A.C. WhiteFoam Smith & Nephew: Renasys GO and Renasys EZ Plus to be used with the Renassys-F/P and Renassys-G Use of the medical devices and applicable consumption items according to manufacturers guidelines and FDA regulations.

Other Names:
  • Vacuum assisted closure
  • Vacuum assisted wound closure
Active Comparator: Standard Wound Therapy
Standard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment)
Other: Standard Wound Therapy
Standard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment)
Other Name: Standard Conventional Wound Therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 6 weeks
  • Signed informed consent form
  • Patient's eligibility of NPWT in the opinion of the treating physician

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480362

Contacts
Contact: Dörthe Seidel 0049(0)2219895726 Doerthe.Seidel@uni-wh.de
Contact: Anna Hörster 0049(0)2219895718 anna.hoerster@uni-wh.de

Locations
Germany
Franziskus-Krankenhaus Berlin, Abteilung für Innere Medizin Active, not recruiting
Berlin, Germany, 10787
Klinikum Bielefeld, Klinik für Allgemeine und Innere Medizin Recruiting
Bielefeld, Germany, 33604
Contact: Karsten Jungheim, Dr. med.    +49 (521) 5813501    waltraud.rothe@klinikumbielefeld.de   
Gerhard Rothenaicher, Facharzt für Chirurgie, München Bogenhausen Active, not recruiting
Bogenhausen, Germany, 81927
Knappschaftskrankenhaus Bottrop Klinik für Gefäßchirurgie Not yet recruiting
Bottrop, Germany, 46242
Contact: Gernold Wozniak, Prof. Dr.    0049(0)20411512 00    gernold.wozniak@kk-bottrop.de   
Tagesklinik Buchloe Recruiting
Buchloe, Germany, 86807
Contact: Walter Wetzel-Roth, Dr. med.    +49 (8241) 911711    info@wetzel.roth.de   
Klinikum Darmstadt, Chirurgische Klinik III - Gefäß- und Endovascularchirurgie Not yet recruiting
Darmstadt, Germany, 64283
Contact: Farzin Adili, PD Dr. med.    +49 (6151) 1078001    farzin.adili@klinikum-darmstadt.de   
Schwarzwald-Baar Klinikum Villingen Schwenningen, Klinik für Gefäßchirurgie Not yet recruiting
Donaueschingen, Germany, 78166
Contact: Andre Glod, Dr. med.    +49 (771) 885601    andre.glod@sbk-vs.de   
Marienhospital Dortmund-Hombruch, Klinik für Innere Medizin / Diabetologie Recruiting
Dortmund, Germany, 44225
Contact: Andreas Patzelt, Dr. med.    +49 (231) 77508120    andreas.patzelt@marien-hostpital-dortmund.de   
Diabetische Schwerpunktparxis Active, not recruiting
Duisburg, Germany, 47119
Klinikum Döbeln Recruiting
Döbeln, Germany, 04720
Contact: Gudrun Hetzel, Dr. med.    +49 (3431) 722101    gudrun.hetzel@klinikum-doebeln.de   
Bürgerhospital, Klinik für Diabetologie und Ernährungsmedizin Not yet recruiting
Frankfurt, Germany, 60318
Contact: Elke Klug    (0049)69-1500-275    cd.moeller@buergerhospital-ffm.de   
Klinikum Frankfurt (Oder), Klinik für Gefäßchirurgie Recruiting
Frankfurt (Oder), Germany, 15236
Contact: Michael Petzold, Dr. med.    +49 (335) 5481600    michael.petzold@klinikumffo.de   
Goethe Universität Frankfurt am Main, Klinik für Gefäß- und Endovascularchirurgie Not yet recruiting
Frankfurt am Main, Germany, 60590
Contact: Thomas Schmitz-Rixen, Prof. Dr.    +49 (69) 63015349    Schmitz-rixen@em.uni-frankfurt.de   
Helfenstein Klinik Geislingen, Allgemein- und Viszeralchirurgie Recruiting
Geislingen, Germany, 73312
Contact: Matthias Hahn, Dr. med.    +49 (7331) 23201    matthias.hahn@helfenstein-klinik.de   
Universitätsklinikum Giessen und Marburg, Medizinische Klinik und Poliklinik III Not yet recruiting
Giessen, Germany, 35392
Contact: Michael Eckhard, Dr. med.    +49 (641) 985 57024    michael.eckhard@innere.med.uni-giessen.de   
Malteser Krankenhaus St. Carolus, Allgemein- und Visceralchirurgie Not yet recruiting
Görlitz, Germany, 02827
Contact: Frank Hübschmann, Dr. med.    +49 (3581) 721130    Frank.Huebschmann@maltheser.org   
ASKLEPIOS Westklinikum Hamburg GmbH Recruiting
Hamburg, Germany, 22559
Contact: Holger Lawall, Dr. med.    +49 (40) 8191 2026    h.lawall@asklepios.com   
Paracelsusklinik am Silbersee, Wundzentrum Hannover Recruiting
Hannover-Langenhagen, Germany, 30851
Contact: Karsten Glockemann, Dr. med.    +49 (511) 7794178    Glockemann@Zentrum-Chirurgie.de   
Klinikum Hildesheim GmbH Active, not recruiting
Hildesheim, Germany, 31135
Wilgard Hunger - Battefeld Active, not recruiting
Jena, Germany, 07743
Städtisches Klinikum Karlsruhe GmbH Recruiting
Karlsruhe, Germany, 76133
Contact: Martin Storck, Prof. Dr.    +49 (721) 974-2301    Martin.Storck@klinikum-karlsruhe.de   
Krankenhaus Porz am Rhein, Klinik für Gefäßchirurgie Recruiting
Köln, Germany, 51149
Contact: Alexandra Zidek    +49 (2203) 5661278    a.zidek@khporz.de   
Gemeinschaftspraxis Schlotmann - Hochlenert - Zavaleta - Haberstock Recruiting
Köln, Germany, 50733
Contact: Dirk Hochlenert, Dr. med.    +49 (221) 9731610    dirk.hochlenert@web.de   
St. Remigius Krankenhaus Opladen Not yet recruiting
Leverkusen, Germany, 51379
Contact: Peter Mauckner, Dr. med.    +49 (2171) 4092522    mauckner@k-plus.de   
Klinikum Ludwigsburg Active, not recruiting
Ludwigsburg, Germany, 71640
Uniklinik Lübeck, Klinik für Allgemeine Chirurgie Active, not recruiting
Lübeck, Germany, 23538
Universitätsklinikum Gießen Marburg, Viszeral-, Thorax- und Gefäßchirurgie Not yet recruiting
Marburg, Germany, 35043
Contact: Carsten Dietz    0049(06421)5862506    dietzc@med.uni-marburg.de   
Kliniken Maria Hilf GmbH Active, not recruiting
Mönchengladbach, Germany, 41061
Städt. Klinikum Bogenhausen Active, not recruiting
München, Germany, 81477
Klinikum Nürnberg Active, not recruiting
Nürnberg, Germany, 90419
Gemeinschaftspraxis Dres. Alter, Heim, Pourhassan Active, not recruiting
Oberhausen, Germany, 46145
Ortenau Klinikum Offenburg, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie Not yet recruiting
Offenburg, Germany, 77654
Contact: Andreas Riemer, Dr. med.    +49 (781) 4720    andreas.riemer@og.ortenau-klinikum.de   
Marienhospital Osnabrück, Klinik für Allgemeine Innere Medizin und Gastroenterologie Active, not recruiting
Osnabrück, Germany, 49074
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie Recruiting
Quedlinburg, Germany, 06484
Contact: Matthias Holfeld, Dr. med.    +49 (3946) 9097026    m.holfeld@klinikum-quedlinburg.de   
Hegau-Bodensee Klinikum Radolfzell (HBK), Klinik für Innere Medizin Recruiting
Radolfzell, Germany, 78315
Contact: Wolf-Rüdiger Klare    +49(7732)88500    wolf-ruediger.klare@hbh-kliniken.de   
Zentrum für Gefäßmedizin Klinikum Südstadt Rostock Active, not recruiting
Rostock, Germany, 18059
Thüringen Kliniken "Georgius Agricola", Klinik für Gefäßchirurgie Recruiting
Saalfeld, Germany, 07318
Contact: Thomas Krönert, Dr. med    +49 (3671) 541263    gefaesschirurgie@thueringen-kliniken.de   
Sponsors and Collaborators
University of Witten/Herdecke
Kinetic Concepts, Inc.
Smith & Nephew Wound Management Inc
Investigators
Principal Investigator: Dörthe Seidel Institut für Forschung in der Operativen Medizin der Privaten Universität Witten / Herdecke gGmbH
Study Chair: Edmund AM Neugebauer, Prof. Dr. Institut für Forschung in der Operativen Medizin der Privaten Universität Witten / Herdecke gGmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Doerthe Seidel, Interim Scientific Leader of the Centre for Clinical Trials and Innovation, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT01480362     History of Changes
Other Study ID Numbers: UWT_1_GKV, DRKS00003347
Study First Received: November 23, 2011
Last Updated: October 31, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Witten/Herdecke:
Diabetic foot wound
Amputation wound
Chronic wound

Additional relevant MeSH terms:
Foot Ulcer
Diabetic Foot
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on April 17, 2014