Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds
DiaFu
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
2 other identifiers
interventional
360
1 country
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 23, 2011
CompletedFirst Posted
Study publicly available on registry
November 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 5, 2020
April 1, 2020
3.3 years
November 23, 2011
April 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of achieved and confirmed wound closures within the maximum study treatment time
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.
16 weeks
Time until wound closure within the maximum study treatment time
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.
16 weeks
Secondary Outcomes (13)
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 size
16 weeks
- +8 more secondary outcomes
Study Arms (2)
Negative Pressure Wound Therapy
EXPERIMENTALThe therapy involves the controlled application of sub-atmospheric pressure to the local wound environment,using a sealed wound dressing connected to a vacuum pump.
Standard Wound Therapy
ACTIVE COMPARATORStandard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment)
Interventions
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.
Standard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Witten/Herdeckelead
- Kinetic Concepts, Inc.collaborator
- Smith & Nephew Wound Management Inccollaborator
Study Sites (42)
Diabetes Klinik GmbH & Co KG
Bad Mergentheim, 97980, Germany
Evangelisches Krankenhaus, Königin Elisabeth Herzberge gGmbH
Berlin, 10365, Germany
Franziskus-Krankenhaus Berlin, Abteilung für Innere Medizin
Berlin, 10787, Germany
Klinikum Bielefeld, Klinik für Allgemeine und Innere Medizin
Bielefeld, 33604, Germany
Gerhard Rothenaicher, Facharzt für Chirurgie, München Bogenhausen
Bogenhausen, 81927, Germany
Knappschaftskrankenhaus Bottrop Klinik für Gefäßchirurgie
Bottrop, 46242, Germany
Tagesklinik Buchloe
Buchloe, 86807, Germany
Gemeinschaftspraxis Schlotmann - Hochlenert - Zavaleta - Haberstock
Cologne, 50733, Germany
Chirurgische Praxisgemeinschaft am Bayenthalgürtel, Praxis Dr. med. Gerald Engels
Cologne, 50968, Germany
Krankenhaus Porz am Rhein, Klinik für Gefäßchirurgie
Cologne, 51149, Germany
Klinikum Darmstadt, Gefäß- und Endovascularchirurgie
Darmstadt, 64283, Germany
Marienhospital Dortmund-Hombruch, Klinik für Innere Medizin / Diabetologie
Dortmund, 44225, Germany
Klinikum Döbeln
Döbeln, 04720, Germany
Diabetische Schwerpunktpraxis
Duisburg, 47119, Germany
Malteser Krankenhaus - St. Franziskus-Hospital, Medizinische Klinik I, Abt. f. Diabetologie
Flensburg, 24939, Germany
Bürgerhospital, Klinik für Diabetologie und Ernährungsmedizin
Frankfurt, 60318, Germany
Klinikum Frankfurt (Oder), Klinik für Gefäßchirurgie
Frankfurt (Oder), 15236, Germany
Goethe Universität Frankfurt am Main, Klinik für Gefäß- und Endovascularchirurgie
Frankfurt am Main, 60590, Germany
Weißeritztal-Kliniken GmbH Klinik für Gefäßchirurgie-, vaskuläre und endovaskuläre Chirurgie, Phlebologie
Freital, 01705, Germany
Helfenstein Klinik Geislingen, Allgemein- und Viszeralchirurgie
Geislingen, 73312, Germany
Asklepios Kliniken Harburg
Hamburg, 21075, Germany
ASKLEPIOS Westklinikum Hamburg GmbH
Hamburg, 22559, Germany
Paracelsusklinik am Silbersee, Wundzentrum Hannover
Hannover-Langenhagen, 30851, Germany
Westküstenklinikum Heide, Klinik für Visceral- und Gefäßchirurgie
Heide, 25746, Germany
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe, 76133, Germany
Alexianer Krankenhaus Krefeld GmbH, Klinik für Allgemein-, Visceral- und Thoraxchirurgie
Krefeld, 47805, Germany
St. Remigius Krankenhaus Opladen
Leverkusen, 51379, Germany
Klinikum Ludwigsburg, Klinik für Gefäßchirurgie, vaskuläre und endovaskuläre Chirurgie
Ludwigsburg, 71640, Germany
Diabetologikum Ludwigshafen, Diabetes-Schwerpunktpraxis
Ludwigshafen, 67059, Germany
Uniklinik Lübeck, Klinik für Allgemeine Chirurgie
Lübeck, 23538, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, 41061, Germany
Städt. Klinikum Bogenhausen
München, 81477, Germany
Institut für Diabetesforschung Münster GmbH
Münster, 48145, Germany
Städtisches Klinikum Neunkirchen gGmbH
Neunkirchen, 66538, Germany
Gemeinschaftspraxis Drs. Alter, Heim, Pourhassan
Oberhausen, 46145, Germany
Ortenau Klinikum Offenburg, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
Offenburg, 77654, Germany
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH, Klinik für Allgemein-, Visceral- und Gefäßchirurgie
Quedlinburg, 06484, Germany
Hegau-Bodensee Klinikum Radolfzell (HBK), Klinik für Innere Medizin
Radolfzell, 78315, Germany
Thüringen Kliniken "Georgius Agricola", Klinik für Gefäßchirurgie
Saalfeld, 07318, Germany
St. Marienkrankenhaus Siegen gGmbH, Klinik für Gastroenterologie
Siegen, 57072, Germany
Mariannen-Hospital Werl, Abteilung für Chirurgie
Werl, 59457, Germany
HSK - Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, 65199, Germany
Related Publications (3)
Seidel D, Mathes T, Lefering R, Storck M, Lawall H, Neugebauer EA. Negative pressure wound therapy versus standard wound care in chronic diabetic foot wounds: study protocol for a randomized controlled trial. Trials. 2014 Aug 27;15:334. doi: 10.1186/1745-6215-15-334.
PMID: 25158846BACKGROUNDSeidel D, Storck M, Lawall H, Wozniak G, Mauckner P, Hochlenert D, Wetzel-Roth W, Sondern K, Hahn M, Rothenaicher G, Kronert T, Zink K, Neugebauer E. Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT. BMJ Open. 2020 Mar 24;10(3):e026345. doi: 10.1136/bmjopen-2018-026345.
PMID: 32209619RESULTSeidel D, Lefering R; DiaFu study group. NPWT resource use compared with standard moist wound care in diabetic foot wounds: DiaFu randomized clinical trial results. J Foot Ankle Res. 2022 Sep 30;15(1):72. doi: 10.1186/s13047-022-00569-w.
PMID: 36180953DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dörthe Seidel
Witten Herdecke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Wound photographs are analysed by blinded outcome assessors
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of division for clinical research at the Institute for Research in Operative Medicine
Study Record Dates
First Submitted
November 23, 2011
First Posted
November 28, 2011
Study Start
November 1, 2011
Primary Completion
February 1, 2015
Study Completion
April 1, 2015
Last Updated
May 5, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share