Remember Me
Or use your Academic/Social account:


Or use your Academic/Social account:


You have just completed your registration at OpenAire.

Before you can login to the site, you will need to activate your account. An e-mail will be sent to you with the proper instructions.


Please note that this site is currently undergoing Beta testing.
Any new content you create is not guaranteed to be present to the final version of the site upon release.

Thank you for your patience,
OpenAire Dev Team.

Close This Message


Verify Password:
Verify E-mail:
*All Fields Are Required.
Please Verify You Are Human:
fbtwitterlinkedinvimeoflicker grey 14rssslideshare1
Shannon, R; Nelson, A (2017)
Publisher: Wiley
Languages: English
Types: Article
To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care (SC) and one matched from four large UK pragmatic, randomised controlled trials [venous leg ulcer (VLU) evidence network]. We introduce a new proof-of-concept strategy to a VLU clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus SC for success in future randomised, controlled clinical trials. Prospective data on chronic VLUs from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score-matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi-layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow-up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the UK (the comparison group; VLU evidence network). Analysis using Kaplan-Meier survival curves showed a mean healing time of 73·1 days for ASM plus SC (ASM) treated ulcers in comparison with 83·5 days for comparison group ulcers treated with SC alone (Log rank test, χ(2) 5·779, P = 0·016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for SC by a factor of 1·1 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to SC in the treatment of non-healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

    • 1. Global Health Economic Projects LLC, Clifton Park, NY, USA
    • 2. Head of School, Professor of Wound Healing, School of Healthcare, University of Leeds, UK
    • 1. Körber A, Klode J, Al-Benna S, Wax C, Schadendorf D, Steinstraesser L, Dissemond J. Etiology of chronic leg ulcers in 31,619 patients in Germany analyzed by an expert survey. J Dtsch Dermatol Ges. 2011 Feb;9(2):116-21.
    • 2. K. Sen C, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy. Wound Repair Regen. 2009; 17(6): 763 771.
    • 3. Mekkes JR, Loots MA, Van Der Wal AC, Bos JD. Causes, investigation and treatment of leg ulceration. Br J Dermatol 2003; 148: 388 401.4.
    • 4. Chen WY, Rogers AA. Recent insights into causes of chronic leg ulceration in venous disease and implications on other types of chronic wounds. Wound Rep Regen 2007; 15: 434-9.
    • 5. van Gent WB, Wilschut ED, Wittens C. Management of venous ulcer disease. BMJ 2010;341:c6045.
    • 6. Posnett J, Franks PJ (2008) The burden of chronic wounds in the UK. Nursing Times; 104: 3, 44- 45.
    • 23. Dumville JC, Worthy G, Bland JM, Cullum N, Dowson C, Iglesias C, Mitchell JL, Nelson EA, Soares MO, Torgerson DJ. Larval therapy for leg ulcers (VenUS II): randomised controlled trial. BMJ 2009; 338:b773.
    • 24. Dumville J, Worthy G, Soares M, Bland JM, Cullum M, Dowson C, et al. VenUS II: a randomised controlled trial of larval therapy in the management of leg ulcers. Health Technol Assess 2009; 13:1-182.
    • 25. Watson JM, Kang'ombe AR, Soares MO, Chuang LH, Worthy G, Bland JM, Iglesias C, Cullum N, Torgerson D, Nelson EA; VenUS III Team. Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: the VenUS III randomised controlled trial. BMJ. 2011 Mar 8; 342:d1092. doi: 10.1136/bmj.d1092.
    • 26. MO, Chuang LH, Worthy G, Bland JM, Iglesias C, Cullum N, Torgerson DJ, Nelson EA. VenUS III: a randomised controlled trial of therapeutic ultrasound in the management of venous leg ulcers. Health Technol Assess 2011; 15(13).
    • 27. Ashby RL, Gabe R, Ali S, Adderley U, Bland JM, Cullum NA, Dumville JC, Iglesias CP, Kang'ombe AR, Soares MO, Stubbs NC, Torgerson DJ. 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. Lancet. 2014 Mar 8; 383(9920):871- 9.
    • 28. Ashby RL, Gabe R, Ali S, Saramago P, Chuang LH, Adderley U, Bland JM, Cullum NA, Dumville Ulcer Study IV) compression hosiery compared with compression bandaging in the treatment of venous leg ulcers: a randomised controlled trial, mixed-treatment comparison and decisionanalytic model. Health Technol Assess. 2014 Sep; 18(57):1-293.
    • 29. Harding K, Aldons P, Edwards H, Staycey M, Finlayson K, Gibb M, Jenkins L, Shooter G, Van Lonkhuyzen D, Lynam E, Heinrichs EL, Upton Z. Effectiveness of an acellular synthetic matrix in the treatment of hard-to-heal leg ulcers. International Wounds Journal. Apr. 2014; 11(2):129-137.
    • 30. SIGN Guidelines Venous Leg Ulcer Management (August 2010): http://sign.ac.uk/guidelines/fulltext/120/index.html
    • 31. Soares MO, Iglesias CP, Bland JM, Cullum N, Dumville JC, Nelson EA, Torgerson DJ, Worthy G. Cost effectiveness analysis of larval therapy for leg ulcers. BMJ 2009; 338:b825.
    • 32. Driver VR, Fabbi M. Recent advances in the use of ultrasound in wound care. Adv Wound Care 2010; 1:550-5.
    • 33. Chuang LH, Soares MO, Watson JM, Bland JM, Cullum N, Iglesias C, et al. Economic evaluation of a randomized controlled trial of ultrasound therapy for hard-to-heal venous leg ulcers. Br J Surg 2011; 98:1099-106.
    • 34. O'Donnell TF Jr, Passman MA, Marston WA, Ennis WJ, Dalsing M, Kistner RL, Lurie F, Henke PK, Gloviczki ML, Eklöf BG, Stoughton J, Raju S, Shortell CK, Raffetto JD, Partsch H, Pounds LC, Cummings ME, Gillespie DL, McLafferty RB, Murad MH, Wakefield TW, Gloviczki P. Management of venous leg ulcers: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2014 Aug; 60(2 Suppl):3S-59S.
    • 35. Margolis DJ, Berlin JA, Strom BL. Which venous leg ulcers will heal with limb compression bandages? Am J Med. 2000 Jul; 109(1):15-9.
    • 36. Phillips TJ, Machado F, Trout R, Porter J, Olin J, Falanga V. Prognostic indicators in venous ulcers. J Am Acad Dermatol. 2000 Oct; 43(4):627-30.
    • 37. Moffatt CJ, Doherty DC, Smithdale R, Franks PJ. Clinical Predictors of Leg Ulcer Healing. The British Journal of Dermatology. 2010; 162(1):51-58.
    • 38. Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA. The accuracy of venous leg ulcer prognostic models in a wound care system. Wound Repair Regen. 2004 Mar-Apr; 12(2):163-8.
    • 39. Bosanquet DC, Harding KG. Wound duration and healing rates: Cause or effect? Wound Repair Regen. 2014 Mar; 22(2):143-50. doi: 10.1111/wrr.12149.
    • 40. Margolis DJ, Berlin JA, Strom BL. Risk factors associated with the failure of a venous leg ulcer to heal. Arch Dermatol. 1999 Aug; 135(8):920-6.
    • 41. Kulkarni SR, Gohel MS, Wakely C, Minor J, Poskitt KR, Whyman MR. The Ulcerated Leg Severity Assessment score for prediction of venous leg ulcer healing. Br J Surg. 2007 Feb; 94(2):189-93.
    • 44. R Core Team (2012). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, URL http://www.R-project.org/
    • 45. Thoemmes F. J. (2012). Propensity score matching in SPSS. Journal of Statistical Sciences. Accessed, June 1, 2015, http://arxiv.org/abs/1201.6385
    • 46. Rubin, DB. (1973a). Matching to remove bias in observational studies. Biometrics 29 159 184.
    • 47. Rubin, DB. (1974). Estimating causal effects of treatments in randomized and nonrandomized studies. Journal of Educational Psychology 66 688 701.
    • 48. Conover WJ, Practical Nonparametric Statistics (3rd edition). Wiley 1999.
    • 49. DuNouy PL. Cicatrization of wounds, II: mathematical expression of the curve representing cicatrization. J Exp Med. 1916; 24:451 60.
    • 50. Robson MC, Hill DP, Woodske ME, Steed DL. Wound healing trajectories as predictors of effectiveness of therapeutic agents. Arch Surg. 2000; 135:773 7.
    • 51. Steed DL, Hill DP, Woodske ME, Payne WG, Robson MC. Wound-healing trajectories as outcome measures of venous stasis ulcer treatment. Int Wound J. 2006; 3:40 47.
    • 52. Polansky M, van Rijswijk L. Utilizing survival analysis techniques in chronic wound healing studies. Wounds. 1994; 6:150 8.
    • 53. Telke SE, Eberly LE. Statistical Hypothesis Testing: Associating patient characteristics with an incident condition: Kaplan-meier curves, hazard ratios, and cox proportional hazards regression. J Wound Ostomy Continence Nurs. 2011; 38(6):621-626.
    • 54. Rosenbaum PR. Observational Studies, 2nd Ed. (2002), NY: Springer. Chapter 4; Section 4.4.8.
    • 55. Hansen BB, Bowers J. Covariate balance in simple, stratified and clustered comparative studies. Stat Sci 2008; 23:219-36.
    • 56. Ishak KJ, Proskorovsky I, Benedict A. Simulation and Matching-Based Approaches for Indirect Comparison of Treatments. PharmacoEconomics (2015) 33:537 549.
    • 57. Jansen JP, Fleurence R, Devine B, Itzler R, Barrett A, Hawkins N, Lee K, Boersma C, Annemans L, Cappelleri JC. Interpreting Indirect Treatment Comparisons and Network Meta-Analysis for
  • No related research data.
  • No similar publications.

Share - Bookmark

Cite this article