Clinical and cost-eff effctiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial

Ashby, Rebecca L., Gabe, Rhian, Ali, Shehzad, Adderley, Una, Bland, J. Martin, Cullum, Nicky A., Dumville, Jo C., Iglesias, Cynthia P., Kang'ombe, Arthur R., Soares, Marta O., Stubbs, Nikki C. and Torgerson, David J. (2014) Clinical and cost-eff effctiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. Lancet, 383 9920: 871-879. doi:10.1016/S0140-6736(13)62368-5

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Author Ashby, Rebecca L.
Gabe, Rhian
Ali, Shehzad
Adderley, Una
Bland, J. Martin
Cullum, Nicky A.
Dumville, Jo C.
Iglesias, Cynthia P.
Kang'ombe, Arthur R.
Soares, Marta O.
Stubbs, Nikki C.
Torgerson, David J.
Title Clinical and cost-eff effctiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial
Journal name Lancet   Check publisher's open access policy
ISSN 0140-6736
1474-547X
Publication date 2014-03
Sub-type Article (original research)
DOI 10.1016/S0140-6736(13)62368-5
Open Access Status
Volume 383
Issue 9920
Start page 871
End page 879
Total pages 9
Place of publication London, United Kingdom
Publisher The Lancet
Collection year 2015
Language eng
Formatted 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.

Findings
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.

Interpretation
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.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Nursing, Midwifery and Social Work Publications
 
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Citation counts: TR Web of Science Citation Count  Cited 23 times in Thomson Reuters Web of Science Article | Citations
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Created: Thu, 22 May 2014, 11:58:58 EST by Vicki Percival on behalf of School of Nursing, Midwifery and Social Work