Foot Ulcer, DiabeticDiaFuNCT01480362
Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds
A study testing Negative Pressure Wound Therapy and Standard Wound Therapy in people with Foot Ulcer, Diabetic, run by University of Witten/Herdecke at 42 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Negative Pressure Wound Therapy and Standard Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 42 sitesGermany
- Study dates
- Nov 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Germany42 sites
Diabetes Klinik GmbH & Co KG
Bad Mergentheim, 97980
Evangelisches Krankenhaus, Königin Elisabeth Herzberge gGmbH
Berlin, 10365
Franziskus-Krankenhaus Berlin, Abteilung für Innere Medizin
Berlin, 10787
Klinikum Bielefeld, Klinik für Allgemeine und Innere Medizin
Bielefeld, 33604
Gerhard Rothenaicher, Facharzt für Chirurgie, München Bogenhausen
Bogenhausen, 81927
Knappschaftskrankenhaus Bottrop Klinik für Gefäßchirurgie
Bottrop, 46242
Tagesklinik Buchloe
Buchloe, 86807
Gemeinschaftspraxis Schlotmann - Hochlenert - Zavaleta - Haberstock
Cologne, 50733
Chirurgische Praxisgemeinschaft am Bayenthalgürtel, Praxis Dr. med. Gerald Engels
Cologne, 50968
Krankenhaus Porz am Rhein, Klinik für Gefäßchirurgie
Cologne, 51149
Klinikum Darmstadt, Gefäß- und Endovascularchirurgie
Darmstadt, 64283
Klinikum Döbeln
Döbeln, 04720
Marienhospital Dortmund-Hombruch, Klinik für Innere Medizin / Diabetologie
Dortmund, 44225
Diabetische Schwerpunktpraxis
Duisburg, 47119
Malteser Krankenhaus - St. Franziskus-Hospital, Medizinische Klinik I, Abt. f. Diabetologie
Flensburg, 24939
Bürgerhospital, Klinik für Diabetologie und Ernährungsmedizin
Frankfurt, 60318
Klinikum Frankfurt (Oder), Klinik für Gefäßchirurgie
Frankfurt (Oder), 15236
Goethe Universität Frankfurt am Main, Klinik für Gefäß- und Endovascularchirurgie
Frankfurt am Main, 60590
Weißeritztal-Kliniken GmbH Klinik für Gefäßchirurgie-, vaskuläre und endovaskuläre Chirurgie, Phlebologie
Freital, 01705
Helfenstein Klinik Geislingen, Allgemein- und Viszeralchirurgie
Geislingen, 73312
Asklepios Kliniken Harburg
Hamburg, 21075
ASKLEPIOS Westklinikum Hamburg GmbH
Hamburg, 22559
Paracelsusklinik am Silbersee, Wundzentrum Hannover
Hannover-Langenhagen, 30851
Westküstenklinikum Heide, Klinik für Visceral- und Gefäßchirurgie
Heide, 25746
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe, 76133
Alexianer Krankenhaus Krefeld GmbH, Klinik für Allgemein-, Visceral- und Thoraxchirurgie
Krefeld, 47805
St. Remigius Krankenhaus Opladen
Leverkusen, 51379
Uniklinik Lübeck, Klinik für Allgemeine Chirurgie
Lübeck, 23538
Klinikum Ludwigsburg, Klinik für Gefäßchirurgie, vaskuläre und endovaskuläre Chirurgie
Ludwigsburg, 71640
Diabetologikum Ludwigshafen, Diabetes-Schwerpunktpraxis
Ludwigshafen, 67059
Kliniken Maria Hilf GmbH
Mönchengladbach, 41061
Städt. Klinikum Bogenhausen
München, 81477
Institut für Diabetesforschung Münster GmbH
Münster, 48145
Städtisches Klinikum Neunkirchen gGmbH
Neunkirchen, 66538
Gemeinschaftspraxis Drs. Alter, Heim, Pourhassan
Oberhausen, 46145
Ortenau Klinikum Offenburg, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
Offenburg, 77654
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH, Klinik für Allgemein-, Visceral- und Gefäßchirurgie
Quedlinburg, 06484
Hegau-Bodensee Klinikum Radolfzell (HBK), Klinik für Innere Medizin
Radolfzell, 78315
Thüringen Kliniken "Georgius Agricola", Klinik für Gefäßchirurgie
Saalfeld, 07318
St. Marienkrankenhaus Siegen gGmbH, Klinik für Gastroenterologie
Siegen, 57072
Mariannen-Hospital Werl, Abteilung für Chirurgie
Werl, 59457
HSK - Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, 65199
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Negative Pressure Wound Therapy, Standard Wound Therapy
- Keywords
- Diabetic foot wound, Amputation wound, Chronic wound
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Also called Vacuum assisted closure, Vacuum assisted wound closure
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 TherapyOther
Also called Standard Conventional Wound Therapy
Standard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment)
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | 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. Receives: Device: Negative Pressure Wound Therapy |
| Standard Wound Therapy | Active comparator | Standard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment) Receives: Other: Standard Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 weeks
Secondary outcomes (13)
Time until optimal wound bed preparation
Time until optimal preparation of the wound bed for further therapy (granulation of at least 95%)
Measured: 16 weeks
Time until wound closure within the observation period
Time to reach a complete wound closure within the observation period of 6 months
Measured: 6 months
Recurrences
Recurrences within the observation period of 6 months after complete and confirmed wound closure
Measured: 6 months
Amputations
Appearance and dimension of amputations
Measured: 16 weeks
Wound size
Wound size over time
Measured: 16 weeks
Wound tissue qualities
Proportion of wound tissue qualities over time
Measured: 16 weeks
Number of complete wound closures within the observation period
Number of complete wound closures achieved within the observation period of 6 months
Measured: 6 months
Wound-related pain (Numeric Rating Scale)
Patient's pain measured with a numeric Rating scale at each study visit
Measured: 16 weeks
Quality of Life questionaire (EQ-5D)
EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 6 months
Measured: 6 months
Direct costs
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
Measured: within a maximum treatment time of 16 weeks or until end of therapy
Indirect costs
disability, disability pension, premature death
Measured: within a maximum treatment time of 16 weeks or until end of therapy
Serious adverse events
All adverse events that result in death, are life-threatening, require inpatient hospitalization or causes prolongation of existing hospitalization, result in persistent or significant disability/incapacity, are a congenital anomaly/birth defect, or require intervention to prevent permanent impairment or damage.
Measured: 6 months
Adverse Events
wound specific and device specific adverse events within the maximum study treatment time
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc., Smith & Nephew Wound Management Inc
- Responsible party
- Principal investigator, Doerthe Seidel, University of Witten/Herdecke
- Investigators
- Dörthe Seidel, Principal investigator, Witten Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480362
- Sponsor's protocol ID
- UWT_1_GKV
- Other IDs
- DRKS00003347
- Acronym
- DiaFu
- Status last verified
- Apr 2020
- First submitted
- 23 Nov 2011
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25158846Seidel 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.
PubMed 32209619Seidel 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.
PubMed 36180953
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01480362
- Acronym / sponsor ID
- DiaFu / UWT_1_GKV
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- Diabetic foot wound, Amputation wound, Chronic wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc., Smith & Nephew Wound Management Inc
- Study start
- Nov 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound TherapyThe 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 comparator | Other: Standard Wound TherapyStandard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyAlso: Vacuum assisted closure, Vacuum assisted wound closureUsed 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. | Device | Negative Pressure Wound Therapy |
| Standard Wound TherapyAlso: Standard Conventional Wound TherapyStandard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment) | Other | Standard Wound Therapy |
Primary outcome
Number of achieved and confirmed wound closures within the maximum study treatment time
Time frame: 16 weeks
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.
Time until wound closure within the maximum study treatment time
Time frame: 16 weeks
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.
13 secondary outcomes
Time until optimal wound bed preparation
Time frame: 16 weeks
Time until wound closure within the observation period
Time frame: 6 months
Recurrences
Time frame: 6 months
Amputations
Time frame: 16 weeks
Wound size
Time frame: 16 weeks
Wound tissue qualities
Time frame: 16 weeks
Number of complete wound closures within the observation period
Time frame: 6 months
Wound-related pain (Numeric Rating Scale)
Time frame: 16 weeks
Quality of Life questionaire (EQ-5D)
Time frame: 6 months
Direct costs
Time frame: within a maximum treatment time of 16 weeks or until end of therapy
Indirect costs
Time frame: within a maximum treatment time of 16 weeks or until end of therapy
Serious adverse events
Time frame: 6 months
Adverse Events
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Background: PubMed 25158846Seidel 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.
- Results publication: PubMed 32209619Seidel 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.
- Derived from this study: PubMed 36180953Seidel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dörthe Seidel principal investigator
Witten Herdecke University
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy and Standard Wound Therapy in people with Foot Ulcer, Diabetic, run by University of Witten/Herdecke at 42 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of achieved and confirmed wound closures within the maximum study treatment time (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480362, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.