Evidence map›Paper›PMID 32209619›Full record

Trial reportBMJ open2020

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.

Dörthe Seidel, Martin Storck, Holger Lawall, Gernold Wozniak, Peter Mauckner, Dirk Hochlenert, Walter Wetzel-Roth, Klemens Sondern, Matthias Hahn, Gerhard Rothenaicher and 3 more

2 registry-linked trialsOpen access · goldAbstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 48 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 11 pooled it
6.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01480362 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of Witten/HerdeckeRan2011 to 2015Enrolled360ConditionsFoot Ulcer, DiabeticArmsNegative Pressure Wound Therapy, Standard Wound Therapy
NCT06721754 narecruitingnot on this mapstarted 2025, after this paper: background citation

Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy: A Randomized Controlled Trial

TypeinterventionalSponsorUniversity Hospital, AkershusRan2025 to 2028Enrolled50ConditionsDiabetic Foot UlcerArmsNegative Pressure Wound Treatment
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 11 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Guideline
  10. Guideline
  11. Pooled it
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 5 countries.

Dörthe SeidelInstitut für Forschung in der Operativen Medizin (IFOM), Universität Witten/Herdecke, Köln, Germany Doerthe.Seidel@uni-wh.de.ORCID 0000-0002-2287-5217
Martin StorckKlinik für Gefäß- und Thoraxchirurgie, Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, Germany.
Holger LawallPraxis für Herzkreislauferkrankungen, Ettlingen, Germany.
Gernold WozniakGefäßchirurgische Klinik, Knappschaftskrankenhaus Bottrop GmbH, Bottrop, Germany.
Peter MaucknerInnere Medizin, St. Remigius Krankenhaus Opladen, Leverkusen, Germany.
Dirk HochlenertGemeinschaftspraxis Schlotmann-Hochlenert-Zavaleta-Haberstock, Köln, Germany.
Walter Wetzel-RothChirurgische Praxis Wetzel-Roth, Buchloe, Germany.
Klemens SondernKlinik für Innere Medizin/Diabetologie, Marien Hospital Dortmund-Hombruch, Dortmund, Germany.
Matthias HahnAllgemein- und Viszeralchirurgie, Helfenstein Klinik, Geisslingen, Germany.
Gerhard RothenaicherChirurgische Praxis Rothenaicher, München, Germany.
Thomas KrönertKlinik für Gefäßchirurgie, Thüringen-Kliniken "Georgius Agricola" GmbH, Saalfeld, Germany.
Karl ZinkDiabetes Klinik, Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany.
Edmund NeugebauerDepartment fur Humanmedizin, Universität Witten/Herdecke, Witten, Germany.
Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin · DEWitten/Herdecke University · DEBühler (Germany) · DEGerman Diabetes Center Mergentheim · DEHelios Kliniken · DEPraxis · EEPraxis für Humangenetik · DEPraxis (United States) · USStädtisches Klinikum Karlsruhe · DESt. Marien Hospital · DESt. Remigius Krankenhaus Opladen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice.

designIn this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool.

settingThis German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care.

participants368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included.

interventionsNPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months.

resultsIn the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI-4.7% - 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT.

conclusionsNPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure. TRIAL REGISTRATION NUMBERS: NCT01480362 and DRKS00003347.

Indexed as

Negative-Pressure Wound TherapyOcclusive DressingsAdultAgedAged, 80 and overDiabetic FootFemaleFollow-Up StudiesGermanyHumansIntention to Treat AnalysisMaleMiddle AgedSeverity of Illness IndexSingle-Blind MethodTreatment Outcomebenefit assessmentdiabetic footnegative pressure wound therapywound carewound healingwound treatment

Identifiers

PMID32209619
PMCPMC7202734
OpenAlexW3013119456

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.