NIHR DC Discover

NIHR Signal Long lasting ulcers below the knee are more common than previously thought

Published on 8 November 2016

doi: 10.3310/signal-000326

Long lasting leg or foot ulcers, those that take more than six weeks to heal, affect about 15 in every 10,000 people. They are expensive to treat and often affect people with other health problems too. This estimate was higher than expected. Based on the previous state of knowledge it was thought that 5 in every 10,000 people, at any one time, had open leg ulcers. The researchers thought these estimates were imprecise and wanted to improve them.

A five-year programme on complex wounds has highlighted a lack of good quality patient centred research on best management despite looking carefully for existing trials on the topic. Complex wounds, caused by conditions such as leg and foot ulcers, are often left open to heal by themselves. Healing can take time and in some cases the wound may never heal completely. This can have a major impact upon quality of life.

This research, undertaken as part of the NIHR-funded programme, included eleven new and updated reviews of the existing literature, a survey and interviews with people with complex wounds, their carers and healthcare professionals.

It identified a top 12 list of priorities for future research and practice needs to focus on the outcomes that matter to people with complex wounds. Social consequences are of particular concern, and when healing is unrealistic or liable to take time, people need greater support managing what may become a long term condition.

Share your views on the research.

Why was this study needed?

This was the first high quality study to look for the prevalence of all kinds of complex wounds. Previous studies of prevalence for all types of ulcers had estimated a prevalence of 0.05% (5 per 10,000 people). Complex wounds (sometimes known as chronic wounds) involve superficial, partial or full-thickness skin loss being treated by secondary intention. This means the wound is left open to heal as opposed to being closed by stitches or similar. Complex wounds often stem from conditions such as pressure ulcers and diabetic foot ulcers and tend to be treated by nurses in the community. The cost of delivering care to people with complex wounds is unclear, but will be high. Community prescribing costs alone for wound dressings were £184M in 2012.

No routine data is collected in the UK about complex wound care so we know little about the number of people affected, what treatment they receive, their outcomes and the associated costs. There is also a lack of information about the experience and preferences of people with complex wounds and their carers.

Existing research tends to be of poor quality. The overall aim of this study was to try and fill the gaps in the evidence and to update or undertake new systematic reviews in order to improve the care and outcomes for people with, or at risk of, complex wounds.

What did this study do?

The programme was split into three work streams. The first focused on the number, nature and care of complex wounds. A systematic review of existing prevalence studies was carried out, followed by a survey completed by 1103 people managing care for complex wounds across Leeds.

Work stream two explored the outcomes prioritised by people affected by complex wounds through semi-structured interviews in Leeds with 33 patients, eight carers and 12 healthcare professionals. A review of 167 randomised controlled trials of complex wound outcomes, was used to develop research priorities.

Work stream three identified areas of high decision uncertainty through consultation with NHS staff in Leeds and then conducted or updated Cochrane reviews in several complex wound topic areas.

Most underlying studies on which these reviews were based were at unclear risk of bias and they recruited small numbers of participants with short durations of follow-up, meaning that any estimate of effect is uncertain.

What did it find?

  • The prevalence of complex wounds in Leeds was estimated as 1.47 per 1000 population (95% confidence interval 1.38 to 1.56 per 1000 population).
  • A primary dressing was reported in 1326 of 1416 wounds (93.6%). The most frequently reported primary dressing were non- and low-adherence wound contact dressings (26.3%).
  • Most patients (29 out of 33) said the outcome they most wanted from treatment is healing. When asked what bothered them most about the wound, six people said pain, five the social embarrassment of the smell and three the social embarrassment of leakage. A further two said the boredom due to confinement to the bed/house, two sited itching, two the threat of infection and one the strangeness of not having pain.
  • Eleven Cochrane reviews were undertaken or updated: five in diabetic foot ulcers, five in venous leg ulcers and one in surgical wounds. The number of included RCTs ranged from 5 to 48. These identified several potentially effective wound treatments. Matrix hydrocolloid dressing had the highest probability (70%) of being the best dressing for diabetic foot ulcers, whereas a hyaluronan fleece dressing had the highest probability (35%) of being the best for venous ulcers.

What does current guidance say on this issue?

There is UK guidance on the prevention and management of complex wounds. Complex wounds from diabetes are covered by NICE 2016 guidelines on the prevention and management of diabetic foot problems, and other guidelines cover the prevention and management of pressure ulcers (2014) and SIGN management of chronic venous leg ulcers (2010). These give some suggestions of what to do and what not to try but in general do not focus on comparing dressings against each other. They do not cover the psychological and social impact of living with this long-term condition.

What are the implications?

More good quality research needs to be conducted to lessen treatment uncertainties and provide specific guidance. As it stands, wound care services are often centred on the physical rather than psychological or social impacts of having a complex wound.

As such a shift needs to occur in terms of how complex wounds are viewed. As opposed to just focusing on healing, more emphasis needs to be placed upon the possibility of having to live with a long term condition. This would help support not only people with complex wounds but also their carers and healthcare professionals.

Citation and Funding

Cullum N, Buckley H, Dumville J, et al. Wounds research for patient benefit: a 5-year programme of research. Programme Grants Appl Res. 2016;4(13).

This project was funded by the National Institute for Health Research Programme Grants for Applied Research (project number RP-PG-0407-10428).

Bibliography

Briggs M, Nelson EA, Martyn-St James M. Topical agents or dressings for pain in venous leg ulcers. Cochrane Database Syst Rev. 2012;11:CD001177.

Dumville J, O’Meara S, Deshpande S, Speak K. Alginate dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;6:CD009110.

Dumville J, Deshpande S, O’Meara S, Speak K. Foam dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;6:CD009111.

Dumville J, Deshpande S, O’Meara S, Speak K. Hydrocolloid dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;8:CD009099.

Dumville J, O’Meara S, Deshpande S, Speak K. Hydrogel dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;7:CD009101.

Dumville J, Hinchliffe R, Cullum N, Game F, et al. Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus. Cochrane Database Syst Rev. 2013;10:CD010318.

Dumville JC, McFarlane E, Edwards P, et al. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013;3:CD003949.

NICE. Diabetic foot problems: prevention and management. NG19. London: National Institute for Health and Care Excellence; 2016.

NICE. Prevention and management of pressure ulcers . CG179. London: National Institute for Health and Care Excellence; 2014.

O’Meara S, Martyn-St James M. Alginate dressings for venous leg ulcers. Cochrane Database Syst Rev. 2013;4:CD010182.

O’Meara S, Martyn-St James M. Foam dressings for venous leg ulcers. Cochrane Database Syst Rev. 2013;5:CD009907.

O’Meara S, Al-Kurdi D, Ologun Y, et al. Antibiotics and antiseptics for venous leg ulcers. Cochrane Database Syst Rev. 2013;12:CD003557.

O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2012;11:CD000265.

SIGN. Management of chronic venous leg ulcers. Edinburgh: Scottish Intercollegiate Guidelines Network; 2010.

Why was this study needed?

This was the first high quality study to look for the prevalence of all kinds of complex wounds. Previous studies of prevalence for all types of ulcers had estimated a prevalence of 0.05% (5 per 10,000 people). Complex wounds (sometimes known as chronic wounds) involve superficial, partial or full-thickness skin loss being treated by secondary intention. This means the wound is left open to heal as opposed to being closed by stitches or similar. Complex wounds often stem from conditions such as pressure ulcers and diabetic foot ulcers and tend to be treated by nurses in the community. The cost of delivering care to people with complex wounds is unclear, but will be high. Community prescribing costs alone for wound dressings were £184M in 2012.

No routine data is collected in the UK about complex wound care so we know little about the number of people affected, what treatment they receive, their outcomes and the associated costs. There is also a lack of information about the experience and preferences of people with complex wounds and their carers.

Existing research tends to be of poor quality. The overall aim of this study was to try and fill the gaps in the evidence and to update or undertake new systematic reviews in order to improve the care and outcomes for people with, or at risk of, complex wounds.

What did this study do?

The programme was split into three work streams. The first focused on the number, nature and care of complex wounds. A systematic review of existing prevalence studies was carried out, followed by a survey completed by 1103 people managing care for complex wounds across Leeds.

Work stream two explored the outcomes prioritised by people affected by complex wounds through semi-structured interviews in Leeds with 33 patients, eight carers and 12 healthcare professionals. A review of 167 randomised controlled trials of complex wound outcomes, was used to develop research priorities.

Work stream three identified areas of high decision uncertainty through consultation with NHS staff in Leeds and then conducted or updated Cochrane reviews in several complex wound topic areas.

Most underlying studies on which these reviews were based were at unclear risk of bias and they recruited small numbers of participants with short durations of follow-up, meaning that any estimate of effect is uncertain.

What did it find?

  • The prevalence of complex wounds in Leeds was estimated as 1.47 per 1000 population (95% confidence interval 1.38 to 1.56 per 1000 population).
  • A primary dressing was reported in 1326 of 1416 wounds (93.6%). The most frequently reported primary dressing were non- and low-adherence wound contact dressings (26.3%).
  • Most patients (29 out of 33) said the outcome they most wanted from treatment is healing. When asked what bothered them most about the wound, six people said pain, five the social embarrassment of the smell and three the social embarrassment of leakage. A further two said the boredom due to confinement to the bed/house, two sited itching, two the threat of infection and one the strangeness of not having pain.
  • Eleven Cochrane reviews were undertaken or updated: five in diabetic foot ulcers, five in venous leg ulcers and one in surgical wounds. The number of included RCTs ranged from 5 to 48. These identified several potentially effective wound treatments. Matrix hydrocolloid dressing had the highest probability (70%) of being the best dressing for diabetic foot ulcers, whereas a hyaluronan fleece dressing had the highest probability (35%) of being the best for venous ulcers.

What does current guidance say on this issue?

There is UK guidance on the prevention and management of complex wounds. Complex wounds from diabetes are covered by NICE 2016 guidelines on the prevention and management of diabetic foot problems, and other guidelines cover the prevention and management of pressure ulcers (2014) and SIGN management of chronic venous leg ulcers (2010). These give some suggestions of what to do and what not to try but in general do not focus on comparing dressings against each other. They do not cover the psychological and social impact of living with this long-term condition.

What are the implications?

More good quality research needs to be conducted to lessen treatment uncertainties and provide specific guidance. As it stands, wound care services are often centred on the physical rather than psychological or social impacts of having a complex wound.

As such a shift needs to occur in terms of how complex wounds are viewed. As opposed to just focusing on healing, more emphasis needs to be placed upon the possibility of having to live with a long term condition. This would help support not only people with complex wounds but also their carers and healthcare professionals.

Citation and Funding

Cullum N, Buckley H, Dumville J, et al. Wounds research for patient benefit: a 5-year programme of research. Programme Grants Appl Res. 2016;4(13).

This project was funded by the National Institute for Health Research Programme Grants for Applied Research (project number RP-PG-0407-10428).

Bibliography

Briggs M, Nelson EA, Martyn-St James M. Topical agents or dressings for pain in venous leg ulcers. Cochrane Database Syst Rev. 2012;11:CD001177.

Dumville J, O’Meara S, Deshpande S, Speak K. Alginate dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;6:CD009110.

Dumville J, Deshpande S, O’Meara S, Speak K. Foam dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;6:CD009111.

Dumville J, Deshpande S, O’Meara S, Speak K. Hydrocolloid dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;8:CD009099.

Dumville J, O’Meara S, Deshpande S, Speak K. Hydrogel dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;7:CD009101.

Dumville J, Hinchliffe R, Cullum N, Game F, et al. Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus. Cochrane Database Syst Rev. 2013;10:CD010318.

Dumville JC, McFarlane E, Edwards P, et al. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013;3:CD003949.

NICE. Diabetic foot problems: prevention and management. NG19. London: National Institute for Health and Care Excellence; 2016.

NICE. Prevention and management of pressure ulcers . CG179. London: National Institute for Health and Care Excellence; 2014.

O’Meara S, Martyn-St James M. Alginate dressings for venous leg ulcers. Cochrane Database Syst Rev. 2013;4:CD010182.

O’Meara S, Martyn-St James M. Foam dressings for venous leg ulcers. Cochrane Database Syst Rev. 2013;5:CD009907.

O’Meara S, Al-Kurdi D, Ologun Y, et al. Antibiotics and antiseptics for venous leg ulcers. Cochrane Database Syst Rev. 2013;12:CD003557.

O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2012;11:CD000265.

SIGN. Management of chronic venous leg ulcers. Edinburgh: Scottish Intercollegiate Guidelines Network; 2010.

Wounds research for patient benefit: a 5-year programme of research

Published on 1 September 2016

Cullum N, Buckley H, Dumville J, Hall J, Lamb K, Madden M, Morley R, O'Meara S, Saramago Goncalves P, Soares M, Stubbs N.

Programme Grants for Applied Research Volume 4 Issue 13 , 2016

Background Complex wounds are those that heal by secondary intention and include lower-limb ulcers, pressure ulcers and some surgical wounds. The care of people with complex wounds is costly, with care mainly being delivered by community nurses. There is a lack of current, high-quality data regarding the numbers and types of people affected, care received and outcomes achieved. Objectives To (1) assess how high-quality data about complex wounds can be captured effectively for use in both service planning and research while ensuring integration with current clinical data collection systems and minimal impact on staff time; (2) investigate whether or not a clinical register of people with complex wounds could give valid estimates of treatment effects, thus reducing dependence on large-scale randomised controlled trials (RCTs); (3) identify the most important research questions and outcomes for people with complex wounds from the perspectives of patients, carers and health-care professionals; (4) evaluate the potential contributions to decision-making of individual patient data meta-analysis and mixed treatment comparison meta-analysis; and (5) complete and update systematic reviews in topic areas of high priority. Methods To meet objectives 1 and 2 we conducted a prevalence survey and developed and piloted a longitudinal disease register. A consultative, deliberative method and in-depth interviews were undertaken to address objective 3. To address objectives 4 and 5 we conducted systematic reviews including mixed treatment comparison meta-analysis. Results From the prevalence survey we estimated the point prevalence of all complex wounds to be 1.47 per 1000 people (95% confidence interval 1.38 to 1.56 per 1000 people). Pressure ulcers and venous leg ulcers were the most common type of complex wound. A total of 195 people with a complex wound were recruited to a complex wounds register pilot. We established the feasibility of correctly identifying, extracting and transferring routine NHS data into the register; however, participant recruitment, data collection and tracking individual wounds in people with multiple wounds were challenging. Most patients and health professionals regarded healing of the wound as the primary treatment goal. Patients were greatly troubled by the social consequences of having a complex wound. Complex wounds are frequently a consequence of, and are themselves, a long-term condition but treatment is usually focused on healing the wound. Consultative, deliberative research agenda setting on pressure ulcer prevention and treatment with patients, carers and clinicians yielded 960 treatment uncertainties and a top 12 list of research priorities. Of 167 RCTs of complex wound treatments in a systematic review of study quality, 41% did not specify a primary outcome and the overall quality of the conduct and reporting of the research was poor. Mixed-treatment comparison meta-analysis in areas of high priority identified that matrix hydrocolloid dressings had the highest probability (70%) of being the most effective dressing for diabetic foot ulcers, whereas a hyaluronan fleece dressing had the highest probability (35%) of being the most effective dressing for venous ulcers; however, the quality of this evidence was low and uncertainty is high. Conclusions Complex wounds are common and costly with a poor evidence base for many frequent clinical decisions. There is little routine clinical data collection in community nursing. A prospective complex wounds register has the potential to both assist clinical decision-making and provide important research evidence but would be challenging to implement without investment in information technology in NHS community services. Future work should focus on developing insights into typical wound healing trajectories, identifying factors that are prognostic for healing and assessing the cost-effectiveness of selected wound treatments. Funding The National Institute for Health Research Programme Grants for Applied Research programme.

Expert commentary

The costs of managing complex wounds in terms of wound dressings, staff time and hospitalisation are currently high. There are implications for service planning in terms of being able to target research activity to reduce the number and frequency of consultations, and being cost-effective in wound product choice. A register of complex wounds, their treatment and outcomes would inform service plans and workforce development. 

Desired outcomes for patients should also be made explicit and a consequent shift in focus from ‘healing’ to ‘living with’ in order to address their needs. Working with patients to identify research priorities, a way forward to improve evidence of effective treatments and patient outcomes will inform future programmes of research and improve the evidence-base.

Dr Caroline Dickson, Senior Lecturer in Community Nursing, Queen Margaret University