Health Technology Assessment 2009; Vol. 13: No. 54 Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes WJ Jeffcoate, PE Price, CJ Phillips, FL Game, E Mudge, S Davies, CM Amery, ME Edmonds, OM Gibby, AB Johnson, GR Jones, E Masson, JE Patmore, D Price, G Rayman and KG Harding November 2009 DOI: 10.3310/hta13540 Health Technology Assessment NIHR HTA programme www.hta.ac.uk HTA How to obtain copies of this and other HTA programme reports An electronic version of this publication, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable CD-ROM is also available (see below). Printed copies of HTA monographs cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our Despatch Agents. Non-UK purchasers will have to pay a small fee for post and packing. 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Abstract ............................................................ iii Contents ............................................................Progress.of.the.study. .................................... v . 51 Contribution.of.authors.and.collaborators. .. 51 Randomised controlled trial of the use List of abbreviationsTrial.Steering ...........................................Committee. ............................ vii . 51 Data.Monitoring.and.Ethics.Committee. .... 51 of three dressing preparations in the Executive summary ........................................... ix References ......................................................... 53 management of chronic ulceration of the Chapter 1 BackgroundAppendix ................................................1 . 1 foot in diabetes IntroductionIndications. ................................................ for taking other medications. 1 during the course Evidenceof. basethe study.for.effectiveness ..................................................of.management.strategies. 55 1 IssuesAppendix.surrounding 2 .the.choice.of.outcome.measures. .. 2 1* 2 3 Cost-effectivenessAll other medications. ........................................ taken during the. 2 course of the study . WJ Jeffcoate, PE Price, CJ Phillips, Objectives................................................................... .................................................... 2 59 FL Game,1 E Mudge,2 S Davies,3 CM Amery,4 ChapterAppendix 2 3 ME Edmonds,5 OM Gibby,6 AB Johnson,7 Study designMethods and of methods off-loading ......................... by dressing allocation. 5 69 Design. ......................................................... 5 GR Jones,8 E Masson,9 JE Patmore,9 D Price,10 RandomisationAppendix 4 . ............................................ 5 11 2 Setting.Reasons......................................................... for withdrawal by dressing .allocation5 73 G Rayman and KG Harding Target.population. ....................................... 5 InclusionAppendix.criteria 5 . ......................................... 5 1Nottingham University Hospitals Trust, Nottingham, UK ExclusionSerious.criteria adverse. ........................................ events ................................ 5 . 75 2Department of Wound Healing, School of Medicine, Cardiff University, UK Baseline.assessment. .................................... 6 3Institute of Health Research, Swansea University, UK Appendix 6 Clinical.care. ................................................ 6 4Leeds General Infirmary, Leeds, UK WithdrawalChanges. .................................................. in cross-sectional area of the. ulcers7 between 5 End.pointsbaseline. .................................................. and visits . 7 Kings College Hospital, London, UK Economic7 (12.evaluation weeks) and. .................................. 13 (24 weeks) .................. 7 . 79 6Royal Gwent Hospital, Newport, UK Sample.size. ................................................. 9 7Southmead Hospital, Bristol, UK DataAppendix.management 7 . ...................................... 9 8East Lancashire Hospitals NHS Trust, Blackburn, UK DeviationsBaseline.from .demographicsthe.planned.protocol by outcome. ....... .status9 85 9Hull Royal Infirmary, Hull, UK 10Singleton and Morriston Hospitals, Swansea, UK ChapterHealth 3 Technology Assessment reports published to date . 11 Results.................................................................. ........................................................ 11 87 Ipswich Hospital, Ipswich, UK Recruitment,.retention.and.primary.outcome 11 DemographicsHealth Technology.of.participants Assessment. .................... 11 *Corresponding author Total.medicationsprogramme.prescribed .................................................. ...................... 13 .107 Ulcer.characteristics.at.baseline. ................. 13 Declared competing interests of authors: none Methods.of.off-loading.used.at.visit.1. ........ 16 Primary.outcome.–.incidence.of.healing. .... 16 Secondary.outcomes.–.. Published November 2009 ulcer-related.outcomes. ........................... 23 Secondary.outcomes.–.patient-related.outcomes 28 DOI: 10.3310/hta13540 Secondary.outcomes.–.process-related.outcomes 31 Health.economic.analysis. ........................... 32 This report should be referenced as follows: Data.not.presented. ..................................... 43 Jeffcoate WJ, Price PE, Phillips CJ, Game FL, Mudge E, Davies S, et al. Randomised controlled trial of Chapter 4 the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes. Discussion ................................................... 45 Health Technol Assess 2009;13(54). Cost-effectiveness.analysis. .......................... 47 Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Excerpta Medica/ Chapter 5 EMBASE, Science Citation Index Expanded (SciSearch®) and Current Contents®/Clinical Medicine. Conclusions ................................................. 49 Acknowledgements .......................................... 51 Participating.centres. ................................... 51 NIHR Health Technology Assessment programme he.Health.Technology.Assessment.(HTA).programme,.part.of.the.National.Institute.for.Health. TResearch.(NIHR),.was.set.up.in.1993..It.produces.high-quality.research.information.on.the. effectiveness,.costs.and.broader.impact.of.health.technologies.for.those.who.use,.manage.and.provide.care. in.the.NHS..‘Health.technologies’.are.broadly.defined.as.all.interventions.used.to.promote.health,.prevent. and.treat.disease,.and.improve.rehabilitation.and.long-term.care. The.research.findings.from.the.HTA.programme.directly.influence.decision-making.bodies.such.as.the. National.Institute.for.Health.and.Clinical.Excellence.(NICE).and.the.National.Screening.Committee. (NSC)..HTA.findings.also.help.to.improve.the.quality.of.clinical.practice.in.the.NHS.indirectly.in.that.they. form.a.key.component.of.the.‘National.Knowledge.Service’. The.HTA.programme.is.needs.led.in.that.it.fills.gaps.in.the.evidence.needed.by.the.NHS..There.are.three. routes.to.the.start.of.projects. First.is.the.commissioned.route..Suggestions.for.research.are.actively.sought.from.people.working.in.the. NHS,.from.the.public.and.consumer.groups.and.from.professional.bodies.such.as.royal.colleges.and.NHS. trusts..These.suggestions.are.carefully.prioritised.by.panels.of.independent.experts.(including.NHS.service. users)..The.HTA.programme.then.commissions.the.research.by.competitive.tender. Second,.the.HTA.programme.provides.grants.for.clinical.trials.for.researchers.who.identify.research.