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 (2024)

Ashby, R. L., Gabe, R., Ali, S., Adderley, U., Bland, J. M., Cullum, N. A., Dumville, J. C., Iglesias, C. P., Kangombe, A. R., Soares, M. O., Stubbs, N. C., & Torgerson, D. J. (2014). 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. The Lancet, 383(9920), 871-879. https://doi.org/10.1016/S0140-6736(13)62368-5

Ashby, Rebecca L. ; Gabe, Rhian ; Ali, Shehzad et al. / 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. In: The Lancet. 2014 ; Vol. 383, No. 9920. pp. 871-879.

@article{9b63aacc10e745d2aedd1bee4e8176e5,

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. 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.",

author = "Ashby, {Rebecca L.} and Rhian Gabe and Shehzad Ali and Una Adderley and Bland, {J. Martin} and Cullum, {Nicky A.} and Dumville, {Jo C.} and Iglesias, {Cynthia P.} and Kangombe, {Arthur R.} and Soares, {Marta O.} and Stubbs, {Nikki C.} and Torgerson, {David J.}",

year = "2014",

doi = "10.1016/S0140-6736(13)62368-5",

language = "English",

volume = "383",

pages = "871--879",

journal = "The Lancet",

issn = "0140-6736",

publisher = "The Lancet",

number = "9920",

}

Ashby, RL, Gabe, R, Ali, S, Adderley, U, Bland, JM, Cullum, NA, Dumville, JC, Iglesias, CP, Kangombe, AR, Soares, MO, Stubbs, NC & Torgerson, DJ 2014, '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', The Lancet, vol. 383, no. 9920, pp. 871-879. https://doi.org/10.1016/S0140-6736(13)62368-5

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. / Ashby, Rebecca L.; Gabe, Rhian; Ali, Shehzad et al.
In: The Lancet, Vol. 383, No. 9920, 2014, p. 871-879.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Ashby, Rebecca L.

AU - Gabe, Rhian

AU - Ali, Shehzad

AU - Adderley, Una

AU - Bland, J. Martin

AU - Cullum, Nicky A.

AU - Dumville, Jo C.

AU - Iglesias, Cynthia P.

AU - Kangombe, Arthur R.

AU - Soares, Marta O.

AU - Stubbs, Nikki C.

AU - Torgerson, David J.

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

U2 - 10.1016/S0140-6736(13)62368-5

DO - 10.1016/S0140-6736(13)62368-5

M3 - Article

C2 - 24315520

SN - 0140-6736

VL - 383

SP - 871

EP - 879

JO - The Lancet

JF - The Lancet

IS - 9920

ER -

Ashby RL, Gabe R, Ali S, Adderley U, Bland JM, Cullum NA et al. 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. The Lancet. 2014;383(9920):871-879. doi: 10.1016/S0140-6736(13)62368-5