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:
University of Witten/Herdecke
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
|
|
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 May 22, 2013