title: Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial.
abstract: BACKGROUND
  Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers.
  
  
  METHODS
  We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072.
  
  
  RESULTS
  We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment.
  
  
  CONCLUSIONS
  Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients.
  
  
  BACKGROUND
  NIHR Health Technology Assessment programme (07/60/26).
authors: Department of Health Sciences, University of York, York, UK.
authors: Rebecca L
authors: RL
authors: Ashby
authors: Department of Health Sciences, University of York, York, UK.
authors: Rhian
authors: R
authors: Gabe
authors: Department of Health Sciences, University of York, York, UK.
authors: Shehzad
authors: S
authors: Ali
authors: School of Healthcare, University of Leeds, Leeds, UK.
authors: Una
authors: U
authors: Adderley
authors: Department of Health Sciences, University of York, York, UK.
authors: J Martin
authors: JM
authors: Bland
authors: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
authors: Nicky A
authors: NA
authors: Cullum
authors: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK. Electronic address: jo.dumville@manchester.ac.uk.
authors: Jo C
authors: JC
authors: Dumville
authors: Department of Health Sciences, University of York, York, UK.
authors: Cynthia P
authors: CP
authors: Iglesias
authors: Liverpool School of Tropical Medicine, Liverpool, UK.
authors: Arthur R
authors: AR
authors: Kang'ombe
authors: Centre for Health Economics, University of York, York, UK.
authors: Marta O
authors: MO
authors: Soares
authors: Leeds Community Healthcare Trust, Leeds, UK.
authors: Nikki C
authors: NC
authors: Stubbs
authors: Department of Health Sciences, University of York, York, UK.
authors: David J
authors: DJ
authors: Torgerson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D058128:Compression Bandages / Q000009:adverse effects / Q000191:economics; D003362:Cost-Benefit Analysis; D004739:England; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009660:Northern Ireland; D019057:Quality-Adjusted Life Years; D053828:Stockings, Compression / Q000009:adverse effects / Q000191:economics; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000191:economics / Q000628:therapy*; D014945:Wound Healing