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

This study is ongoing, but not recruiting participants.
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: January 13, 2015
Last verified: January 2015
  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 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.


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

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 6 months ] [ Designated as safety issue: No ]
    Time to reach a complete wound closure within the observation period of 6 months

  • Recurrences [ Time Frame: within the observation period of 6 months ] [ Designated as safety issue: No ]
    Recurrences within the observation period of 6 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 ]
  • 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 6 months ] [ Designated as safety issue: No ]
    EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 6 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 6 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


Enrollment: 360
Study Start Date: November 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (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 4 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480362

Locations
Germany
Diabetes Klinik GmbH & Co KG
Bad Mergentheim, Germany, 97980
Evangelisches Krankenhaus, Königin Elisabeth Herzberge gGmbH
Berlin, Germany, 10365
Franziskus-Krankenhaus Berlin, Abteilung für Innere Medizin
Berlin, Germany, 10787
Klinikum Bielefeld, Klinik für Allgemeine und Innere Medizin
Bielefeld, Germany, 33604
Gerhard Rothenaicher, Facharzt für Chirurgie, München Bogenhausen
Bogenhausen, Germany, 81927
Knappschaftskrankenhaus Bottrop Klinik für Gefäßchirurgie
Bottrop, Germany, 46242
Tagesklinik Buchloe
Buchloe, Germany, 86807
Klinikum Darmstadt, Gefäß- und Endovascularchirurgie
Darmstadt, Germany, 64283
Marienhospital Dortmund-Hombruch, Klinik für Innere Medizin / Diabetologie
Dortmund, Germany, 44225
Diabetische Schwerpunktpraxis
Duisburg, Germany, 47119
Klinikum Döbeln
Döbeln, Germany, 04720
Malteser Krankenhaus - St. Franziskus-Hospital, Medizinische Klinik I, Abt. f. Diabetologie
Flensburg, Germany, 24939
Bürgerhospital, Klinik für Diabetologie und Ernährungsmedizin
Frankfurt, Germany, 60318
Klinikum Frankfurt (Oder), Klinik für Gefäßchirurgie
Frankfurt (Oder), Germany, 15236
Goethe Universität Frankfurt am Main, Klinik für Gefäß- und Endovascularchirurgie
Frankfurt am Main, Germany, 60590
Weißeritztal-Kliniken GmbH Klinik für Gefäßchirurgie-, vaskuläre und endovaskuläre Chirurgie, Phlebologie
Freital, Germany, 01705
Helfenstein Klinik Geislingen, Allgemein- und Viszeralchirurgie
Geislingen, Germany, 73312
Asklepios Kliniken Harburg
Hamburg, Germany, 21075
ASKLEPIOS Westklinikum Hamburg GmbH
Hamburg, Germany, 22559
Paracelsusklinik am Silbersee, Wundzentrum Hannover
Hannover-Langenhagen, Germany, 30851
Westküstenklinikum Heide, Klinik für Visceral- und Gefäßchirurgie
Heide, Germany, 25746
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe, Germany, 76133
Alexianer Krankenhaus Krefeld GmbH, Klinik für Allgemein-, Visceral- und Thoraxchirurgie
Krefeld, Germany, 47805
Krankenhaus Porz am Rhein, Klinik für Gefäßchirurgie
Köln, Germany, 51149
Gemeinschaftspraxis Schlotmann - Hochlenert - Zavaleta - Haberstock
Köln, Germany, 50733
Chirurgische Praxisgemeinschaft am Bayenthalgürtel, Praxis Dr. med. Gerald Engels
Köln, Germany, 50968
St. Remigius Krankenhaus Opladen
Leverkusen, Germany, 51379
Klinikum Ludwigsburg, Klinik für Gefäßchirurgie, vaskuläre und endovaskuläre Chirurgie
Ludwigsburg, Germany, 71640
Diabetologikum Ludwigshafen, Diabetes-Schwerpunktpraxis
Ludwigshafen, Germany, 67059
Uniklinik Lübeck, Klinik für Allgemeine Chirurgie
Lübeck, Germany, 23538
Kliniken Maria Hilf GmbH
Mönchengladbach, Germany, 41061
Städt. Klinikum Bogenhausen
München, Germany, 81477
Institut für Diabetesforschung Münster GmbH
Münster, Germany, 48145
Städtisches Klinikum Neunkirchen gGmbH
Neunkirchen, Germany, 66538
Gemeinschaftspraxis Drs. Alter, Heim, Pourhassan
Oberhausen, Germany, 46145
Ortenau Klinikum Offenburg, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
Offenburg, Germany, 77654
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH, Klinik für Allgemein-, Visceral- und Gefäßchirurgie
Quedlinburg, Germany, 06484
Hegau-Bodensee Klinikum Radolfzell (HBK), Klinik für Innere Medizin
Radolfzell, Germany, 78315
Thüringen Kliniken "Georgius Agricola", Klinik für Gefäßchirurgie
Saalfeld, Germany, 07318
St. Marienkrankenhaus Siegen gGmbH, Klinik für Gastroenterologie
Siegen, Germany, 57072
Mariannen-Hospital Werl, Abteilung für Chirurgie
Werl, Germany, 59457
HSK - Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, Germany, 65199
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 by University of Witten/Herdecke

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: January 13, 2015
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on July 01, 2015