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Rebecca L Ashby 1, Rhian Gabe 1, Shehzad Ali 1, Pedro Saramago 2, Ling-Hsiang Chuang 1, Una Adderley 3, J Martin Bland 1, Nicky A Cullum 4, Jo C Dumville 1,*, Cynthia P Iglesias 1, Arthur R Kang’ombe 5, Marta O Soares 2, Nikki C Stubbs 6, David J Torgerson 1

1 Department of Health Sciences, The University of York, York, UK
2 Centre for Health Economics, The University of York, York, UK
3 School of Healthcare, The University of Leeds, Leeds, UK
4 School of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK
5 Liverpool School of Tropical Medicine, Liverpool, UK
6 St Mary’s Hospital, Leeds, UK
* Corresponding author Email: jo.dumville@manchester.ac.uk

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Abstract

BACKGROUND

Compression is an effective and recommended treatment for venous leg ulcers. Although the four-layer bandage (4LB) is regarded as the gold standard compression system, it is recognised that the amount of compression delivered might be compromised by poor application technique. Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult. Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers. Two-layer hosiery (HH) may be advantageous, as it has reduced bulk, which might enhance ankle or leg mobility and patient adherence. Some patients can also remove and reapply two-layer hosiery, which may encourage self-management and could reduce costs. However, little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering 'high' compression with the 4LB.

OBJECTIVES

Part I To compare the clinical effectiveness and cost-effectiveness of HH and 4LB in terms of time to complete healing of venous leg ulcers. Part II To synthesise the relative effectiveness evidence (for ulcer healing) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison (MTC). Part IIIâ To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers.

DESIGN

Part Iâ A multicentred, pragmatic, two-arm, parallel, open randomised controlled trial (RCT) with an economic evaluation. Part IIâ MTC using all relevant RCT data - including Venous leg Ulcer Study IV (VenUS IV). Part IIIâ A decision-analytic Markov model.

SETTINGS

Part Iâ Community nurse teams or services, general practitioner practices, leg ulcer clinics, tissue viability clinics or services and wound clinics within England and Northern Ireland.

PARTICIPANTS

Part Iâ Patients aged â ¥â 18 years with a venous leg ulcer, who were willing and able to tolerate high compression.

INTERVENTIONS

Part Iâ Participants in the intervention group received HH. The control group received the 4LB, which was applied according to standard practice. Both treatments are designed to deliver 40â mmHg of compression at the ankle. Part II and IIIâ All relevant high-compression treatments including HH, the 4LB and the two-layer bandage (2LB).

MAIN OUTCOME MEASURES

Part I The primary outcome measure was time to healing of the reference ulcer (blinded assessment). Part II Time to ulcer healing. Part III Quality-adjusted life-years (QALYs) and costs.

RESULTS

Part I A total of 457 participants were recruited. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.79 to 1.25; pâ =â 0.96]. Time to ulcer recurrence was significantly shorter in the 4LB group (HRâ =â 0.56, 95% CI 0.33 to 0.94; pâ =â 0.026). In terms of cost-effectiveness, using QALYs as the measure of benefit, HH had a >â 95% probability of being the most cost-effective treatment based on the within-trial analysis. Part IIâ The MTC suggests that the 2LB has the highest probability of ulcer healing compared with other high-compression treatments. However, this evidence is categorised as low to very low quality. Part IIIâ Results suggested that the 2LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers.

CONCLUSIONS

Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4LB. HH may reduce ulcer recurrence rates compared with the 4LB and be a cost-effective treatment. When all available high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the underpinning evidence was sparse and more research is needed. Further research should thus focus on establishing, in a high-quality trial, the effectiveness of this compression system in particular.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN49373072.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 57. See the NIHR Journals Library website for further project information.

Abstract

BACKGROUND

Compression is an effective and recommended treatment for venous leg ulcers. Although the four-layer bandage (4LB) is regarded as the gold standard compression system, it is recognised that the amount of compression delivered might be compromised by poor application technique. Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult. Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers. Two-layer hosiery (HH) may be advantageous, as it has reduced bulk, which might enhance ankle or leg mobility and patient adherence. Some patients can also remove and reapply two-layer hosiery, which may encourage self-management and could reduce costs. However, little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering 'high' compression with the 4LB.

OBJECTIVES

Part I To compare the clinical effectiveness and cost-effectiveness of HH and 4LB in terms of time to complete healing of venous leg ulcers. Part II To synthesise the relative effectiveness evidence (for ulcer healing) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison (MTC). Part IIIâ To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers.

DESIGN

Part Iâ A multicentred, pragmatic, two-arm, parallel, open randomised controlled trial (RCT) with an economic evaluation. Part IIâ MTC using all relevant RCT data - including Venous leg Ulcer Study IV (VenUS IV). Part IIIâ A decision-analytic Markov model.

SETTINGS

Part Iâ Community nurse teams or services, general practitioner practices, leg ulcer clinics, tissue viability clinics or services and wound clinics within England and Northern Ireland.

PARTICIPANTS

Part Iâ Patients aged â ¥â 18 years with a venous leg ulcer, who were willing and able to tolerate high compression.

INTERVENTIONS

Part Iâ Participants in the intervention group received HH. The control group received the 4LB, which was applied according to standard practice. Both treatments are designed to deliver 40â mmHg of compression at the ankle. Part II and IIIâ All relevant high-compression treatments including HH, the 4LB and the two-layer bandage (2LB).

MAIN OUTCOME MEASURES

Part I The primary outcome measure was time to healing of the reference ulcer (blinded assessment). Part II Time to ulcer healing. Part III Quality-adjusted life-years (QALYs) and costs.

RESULTS

Part I A total of 457 participants were recruited. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.79 to 1.25; pâ =â 0.96]. Time to ulcer recurrence was significantly shorter in the 4LB group (HRâ =â 0.56, 95% CI 0.33 to 0.94; pâ =â 0.026). In terms of cost-effectiveness, using QALYs as the measure of benefit, HH had a >â 95% probability of being the most cost-effective treatment based on the within-trial analysis. Part IIâ The MTC suggests that the 2LB has the highest probability of ulcer healing compared with other high-compression treatments. However, this evidence is categorised as low to very low quality. Part IIIâ Results suggested that the 2LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers.

CONCLUSIONS

Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4LB. HH may reduce ulcer recurrence rates compared with the 4LB and be a cost-effective treatment. When all available high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the underpinning evidence was sparse and more research is needed. Further research should thus focus on establishing, in a high-quality trial, the effectiveness of this compression system in particular.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN49373072.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 57. See the NIHR Journals Library website for further project information.

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