Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds

NCT ID: NCT01480362

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-04-30

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.

Detailed Description

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 Inc. 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 (talocrural articulation), which are caused in the context of a diabetic foot syndrome.

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 2015 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.

Conditions

Foot Ulcer, Diabetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Negative Pressure Wound Therapy

The therapy involves the controlled application of sub-atmospheric pressure to the local wound environment,using a sealed wound dressing connected to a vacuum pump.

Group Type: EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type: DEVICE

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

Standard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment)

Group Type: ACTIVE_COMPARATOR

Standard Wound Therapy

Intervention Type: OTHER

Standard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment)

Interventions

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.

Intervention Type: DEVICE

Standard Wound Therapy

Standard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment)

Intervention Type: OTHER

Other Intervention Names

Vacuum assisted closure; Vacuum assisted wound closure; Standard Conventional Wound Therapy

Eligibility 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, 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kinetic Concepts, Inc.

INDUSTRY

Sponsor Role: collaborator

Smith & Nephew Wound Management Inc

INDUSTRY

Sponsor Role: collaborator

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

Doerthe Seidel

Head of division for clinical research at the Institute for Research in Operative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dörthe Seidel

Role: PRINCIPAL_INVESTIGATOR

Witten Herdecke University

Locations

Diabetes Klinik GmbH & Co KG

Bad Mergentheim, , Germany

Evangelisches Krankenhaus, Königin Elisabeth Herzberge gGmbH

Berlin, , Germany

Franziskus-Krankenhaus Berlin, Abteilung für Innere Medizin

Berlin, , Germany

Klinikum Bielefeld, Klinik für Allgemeine und Innere Medizin

Bielefeld, , Germany

Gerhard Rothenaicher, Facharzt für Chirurgie, München Bogenhausen

Bogenhausen, , Germany

Knappschaftskrankenhaus Bottrop Klinik für Gefäßchirurgie

Bottrop, , Germany

Tagesklinik Buchloe

Buchloe, , Germany

Gemeinschaftspraxis Schlotmann - Hochlenert - Zavaleta - Haberstock

Cologne, , Germany

Chirurgische Praxisgemeinschaft am Bayenthalgürtel, Praxis Dr. med. Gerald Engels

Cologne, , Germany

Krankenhaus Porz am Rhein, Klinik für Gefäßchirurgie

Cologne, , Germany

Klinikum Darmstadt, Gefäß- und Endovascularchirurgie

Darmstadt, , Germany

Marienhospital Dortmund-Hombruch, Klinik für Innere Medizin / Diabetologie

Dortmund, , Germany

Klinikum Döbeln

Döbeln, , Germany

Diabetische Schwerpunktpraxis

Duisburg, , Germany

Malteser Krankenhaus - St. Franziskus-Hospital, Medizinische Klinik I, Abt. f. Diabetologie

Flensburg, , Germany

Bürgerhospital, Klinik für Diabetologie und Ernährungsmedizin

Frankfurt, , Germany

Klinikum Frankfurt (Oder), Klinik für Gefäßchirurgie

Frankfurt (Oder), , Germany

Goethe Universität Frankfurt am Main, Klinik für Gefäß- und Endovascularchirurgie

Frankfurt am Main, , Germany

Weißeritztal-Kliniken GmbH Klinik für Gefäßchirurgie-, vaskuläre und endovaskuläre Chirurgie, Phlebologie

Freital, , Germany

Helfenstein Klinik Geislingen, Allgemein- und Viszeralchirurgie

Geislingen, , Germany

Asklepios Kliniken Harburg

Hamburg, , Germany

ASKLEPIOS Westklinikum Hamburg GmbH

Hamburg, , Germany

Paracelsusklinik am Silbersee, Wundzentrum Hannover

Hannover-Langenhagen, , Germany

Westküstenklinikum Heide, Klinik für Visceral- und Gefäßchirurgie

Heide, , Germany

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, , Germany

Alexianer Krankenhaus Krefeld GmbH, Klinik für Allgemein-, Visceral- und Thoraxchirurgie

Krefeld, , Germany

St. Remigius Krankenhaus Opladen

Leverkusen, , Germany

Klinikum Ludwigsburg, Klinik für Gefäßchirurgie, vaskuläre und endovaskuläre Chirurgie

Ludwigsburg, , Germany

Diabetologikum Ludwigshafen, Diabetes-Schwerpunktpraxis

Ludwigshafen, , Germany

Uniklinik Lübeck, Klinik für Allgemeine Chirurgie

Lübeck, , Germany

Kliniken Maria Hilf GmbH

Mönchengladbach, , Germany

Städt. Klinikum Bogenhausen

München, , Germany

Institut für Diabetesforschung Münster GmbH

Münster, , Germany

Städtisches Klinikum Neunkirchen gGmbH

Neunkirchen, , Germany

Gemeinschaftspraxis Drs. Alter, Heim, Pourhassan

Oberhausen, , Germany

Ortenau Klinikum Offenburg, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie

Offenburg, , Germany

Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH, Klinik für Allgemein-, Visceral- und Gefäßchirurgie

Quedlinburg, , Germany

Hegau-Bodensee Klinikum Radolfzell (HBK), Klinik für Innere Medizin

Radolfzell, , Germany

Thüringen Kliniken "Georgius Agricola", Klinik für Gefäßchirurgie

Saalfeld, , Germany

St. Marienkrankenhaus Siegen gGmbH, Klinik für Gastroenterologie

Siegen, , Germany

Mariannen-Hospital Werl, Abteilung für Chirurgie

Werl, , Germany

HSK - Dr. Horst Schmidt Kliniken GmbH

Wiesbaden, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 25158846 (View on PubMed)

Seidel 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.

Reference Type: RESULT

PMID: 32209619 (View on PubMed)

Seidel 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.

Reference Type: DERIVED

PMID: 36180953 (View on PubMed)

Other Identifiers

DRKS00003347

Identifier Type: REGISTRY

Identifier Source: secondary_id

UWT_1_GKV

Identifier Type: -

Identifier Source: org_study_id