Cardiff Wound Impact Schedule Research Articles

Patients with venous leg ulcers can be managed safely in the community ----results of an observational comparison study in Singapore

AimTo examine the healing outcomes of patients with venous leg ulcers requiring compression bandaging in community care versus tertiary care. MethodThis was an analytical observational cohort study. Venous leg ulcer (VLU) patients who required compression bandaging were recruited from an outpatient vascular clinic between May 2021 and August 2022. Eligible patients received two—or four-layer compression bandaging and followed up with the community care or tertiary care centre nurses. The primary outcome was the difference in the total surface area of the VLU after 12 weeks, and the secondary outcome was the patient's quality of life, as measured by the Cardiff Wound Impact Schedule (CWIS). ResultsForty-seven VLU patients were recruited; 27 received compression bandaging in the community care and 20 by the tertiary care centre. Mean age 70 years old (SD 11.04). The two most prevalent comorbidities were hypertension (51.06 %) and diabetes mellitus (38.29 %). Among those who completed follow-up (12 weeks), the median difference of the total surface area of the VLU between community-based care (p = 0.02) versus tertiary-based care (0.003) was significant. However, there was no difference in the healing status between community and tertiary-based care (p = 0.68). There was no difference in the quality of life of patients between groups. ConclusionThis first tropical study comparing VLU healing outcomes between community and tertiary care found no significant difference in healing with compression bandaging by nurses in either setting. However, the small sample size and high dropout rate limit the generalizability of the findings, necessitating a larger-scale study with longer follow-up. Despite these limitations, the study is a crucial step toward improving wound care services in Singapore, and highlights the need for further research to guide future community wound care implementation.

The Impact of Toe Amputation on the Quality of Life of Diabetic Foot Patients: A Cardiff Wound Impact Schedule (CWIS) Evaluation

Background: The treatment and management of diabetic foot significantly impact the quality of life (QoL) of patients, yet studies concerning the effects of toe amputation on QoL are relatively limited. Methods: This study included 12 diabetic foot patients with Wagner Grade 4 who underwent toe amputation. Using the Cardiff Wound Impact Schedule (CWIS), we systematically assessed their QoL before and after the surgery. Results: Data indicated that there were significant improvements in multiple areas of QoL post-surgery. Particularly in the domains of “overall quality of life” and “well-being,” average scores demonstrated noticeable declines compared to pre-surgery levels. Statistical analysis further confirmed the significance of these results. Conclusion: Toe amputation holds significant value in enhancing the QoL for diabetic foot patients. This study provides robust evidence for clinical decision-making, emphasizing that treatment choices should consider the QoL of the patient in addition to physiological outcomes.

A systematic review of the impact of compression therapy on quality of life and pain among people with a venous leg ulcer.

To gain a greater understanding of how compression therapy affects quality of life, this systematic review appraised existing published studies measuring the impact of compression therapy on health quality of life (HRQoL), and pain, among people with venous leg ulcers (VLU). Five databases were searched, and two authors extracted data and appraised the quality of selected papers using the RevMan risk of bias tool. Due to heterogeneity in the types of compression and instruments used to evaluate HRQoL, meta-analysis was not appropriate; thus, a narrative synthesis of findings was undertaken. Ten studies were included, 9 RCTs and one before-after study. The studies employed nine different HRQoL tools to measure the impact of a variety of compression therapy systems, with or without an additional exercise programme, versus other compression systems or usual care, and the results are mixed. With the use of the Cardiff Cardiff Wound Impact Schedule, the SF-8 and the SF-12, study authors found no differences in QoL scores between the study groups. This is similar to one study using QUALYs (Iglesias et al., 2004). Conversely, for studies using EuroQol-5D, VEINES-QOL, SF-36 and CIVIQ-20 differences in QoL scores between the study groups were noted, in favour of the study intervention groups. Two further studies using QUALYs found results that favoured a two-layer cohesive compression bandage and the TLCCB group, respectively. Results for the five studies that assessed pain are also mixed, with one study finding no difference between study groups, one finding that pain increased over the study period and three studies finding that pain reduced in the intervention groups. All studies were assessed as being at risk of bias in one or more domains. Results were varied, reflecting uncertainty in determining the impact of compression therapy on quality of life and pain among people with a venous leg ulcer. The heterogeneity of the compression systems and the measures used to evaluate HRQoL make it a challenge to interpret the overall evidence. Further studies should strive for homogeneity in design, interventions and comparators to enhance both internal and external validity.

Whole versus hole: enabling community nurses to implement holistic wound care.

To improve wound-related quality of life (QoL) in clients with hard-to-heal wounds in their lower limbs and to increase referrals to multidisciplinary teams in the management of care for these clients. This was a quality improvement project with a two-group pretest-posttest interventional evaluation design. We implemented a package of interventions including the WounDS app, education related to wound care, and client engagement through a QoL self-assessment. Wound-related QoL was measured using the Cardiff Wound Impact Schedule and referrals to the multidisciplinary team were tracked through chart audits. We explored nurses' experiences with the interventions through semi-structured interviews. Clients' average ratings for 'wellbeing', 'physical symptoms and daily living', and 'overall QoL' improved by 27%, 38% and 54%, respectively. The number of referrals increased by 78% post intervention. Nurses described the interventions as effective strategies that motivated them to implement a holistic approach to care. The project was successful in creating a culture shift to practice holistic wound care. This package of interventions (WounDS app, education and client self-assessment of QoL) led to improvements in the QoL of clients with hard-to-heal wounds. Further studies are needed to generalise the findings. Strategies for sustainability include forming a champion group and providing the education and decision supports based on nurses' educational needs assessment.

Health-related quality of life predictors in people with chronic wounds

ObjectiveTo assess health-related quality of life and its predictors among people with chronic wounds. Material and methodsA cross-sectional, analytical study was conducted with 85 people with chronic wounds, from July to September 2019, at a university hospital in the state of Paraíba, Brazil. Data were collected using forms and the Cardiff Wound Impact Schedule (CWIS). For data analysis, multiple linear regression was performed. ResultsThe mean quality of life score according to the CWIS was 45.57. The variables gender, marital status, comorbidities, duration of injury and appearance of exudate were negatively associated with the well-being domain. Injury duration, tissue depth, tissue type, and exudate volume were variables negatively associated with physical symptoms and mastery of daily living. Religion, wound origin, duration, lesion size, and tissue depth were negatively associated with the social life domain. ConclusionSociodemographic characteristics and wound-related aspects need to be considered when assessing and caring for patients with chronic wounds to ensure a better quality of life.

Quality of Life and Its Influencing Factors in Chinese Patients with Chronic Wounds.

To explore the factors influencing quality of life in patients with chronic wounds. A total of 138 patients with chronic wounds were included and completed the Chinese version of the Cardiff Wound Impact Schedule, the Hospital Anxiety and Depression Scale, and the Medical Coping Modes Questionnaire after researchers assessed their wound severity. The mean scores of physical symptoms and everyday living, social life, and well-being on the Chinese version of the Cardiff Wound Impact Schedule were 55.65 ± 15.82, 52.69 ± 16.46, and 40.75 ± 13.82, respectively. Multiple regression analysis revealed that depression, coping style, and education level were the primary factors, explaining 51.7% of the variance in physical symptoms and everyday living. Depression and coping style explained 49.6% of the variance in social life. Anxiety and primary disease explained 36.2% of the variance in well-being. The factors influencing quality of life for these Chinese patients with chronic wounds included education level, primary disease, anxiety, depression, and coping style. Speaking with patients about living with a chronic wound and their potential for healing, understanding their fears about significant changes to their life, and encouraging them to accept such changes can be important for patients and their recovery.

QUALIDADE DE VIDA RELACIONADA À SAÚDE DE PESSOAS COM FERIDAS CRÔNICAS E FATORES ASSOCIADOS

ABSTRACT Objective to assess health-related quality of life in people with chronic wounds and its association with sociodemographic and health characteristics. Method a cross-sectional and analytical study conducted with 85 individuals with chronic wounds in a university hospital from Paraíba, Brazil. The data were collected from June to September 2019 through interviews guided by the Medical Outcome Study 36-item Short-Form Health Survey generic Quality of Life assessment instruments and the Cardiff Wound Impact Schedule specific tool for people with chronic wounds. The Student's t, ANOVA, Mann-Whitney's U, Kruskal-Wallis and Kolmogorov-Smirnov tests were applied to analyze the data, with 5% significance. Results there was predominance of aged and married women with venous wounds not healing for over 24 weeks. The mean score of the generic instrument, which was 35.08, indicated a negative association between the physical capacity domain and female gender; as well as between vitality and age over 60 years old; between emotional aspects and marital status; of functional capacity, limitation of physical activity and emotional aspects with lack of religious practices; and of functional capacity with worse financial situation, all with p≤0.042. The specific instrument had a mean score of 45.57 and presented negative associations in the physical domain with female gender; as well as between social life without religious practices and social life with worse financial situation, all with p≤0.047. Conclusion the scores of the specific and generic instruments indicated low Quality of Life influenced by factors such as female gender, advanced age, being divorced/separated, lack of religious practices and having financial problems.

Psychometric Validation of the Cardiff Wound Impact Schedule Questionnaire in a Spanish Population with Diabetic Foot Ulcer

Diabetic foot ulcers (DFU) negatively affect the quality of life (QoL) of people with diabetes. The Cardiff Wound Impact Schedule (CWIS) questionnaire has been designed to measure the QoL of people with chronic foot wounds. However, no studies have been specifically designed to validate this instrument in a Spanish population. In this prospective study, a total of 141 subjects with DFU were recruited. DFU was determined by performing physical examinations. Medical records were exhaustively reviewed to collect clinical variables. The CWIS was transculturally adapted by a group of experts and a group of patients with DFU. The SF-36 and EQ-5D generic instruments were used as reference tools. The questionnaires were administered at 7 days and 4, 12, and 26 weeks after the baseline assessment by personal interview with each of the study subjects. The psychometric properties of the instrument were assessed using statistical methods. The content validity had an average of 3.63 (90.7% of the maximum score of 4). The internal consistency of the CWIS subscales had a standardized Cronbach’s alpha range from 0.715 to 0.797. The reproducibility was moderate with an intraclass correlation coefficient (ICC) range from 0.606 to 0.868. Significant correlations between CWIS domains and SF-36 and EQ-5D subscales were observed, demonstrating a good criterion validity of the CWIS questionnaire (p < 0.001). However, the construct validity of the CWIS was not validated with a comparative fit index (CFI) of 0.69, a root mean square error of approximation (RMSEA) of 0.09, and a standardized root mean square residual (SRMR) of 0.10. The sensitivity to changes over time was optimal in the three domains (i.e., social life, well-being, and physical symptoms) (p < 0.001). In conclusion, the Spanish version of the CWIS shows acceptable psychometric properties to assess the QoL of subjects with DFU, except for its construct validity.

Health-related quality of life in patients with chronic leg ulcers in a developing country

Poverty with inadequate care prolongs duration of ulcers healing with attendant complications. The impact of this on the quality of life of patients in an economic depleted environment needs to be evaluated. Quality of life of patients with chronic leg ulcers was assessed using validated Cardiff wound impact schedule questionnaires in two teaching Hospitals in Nigeria. The result was analyzed using SPSS Version 17 with frequencies and means. Post traumatic ulcers were the most common cause of chronic leg ulcers (33.7%), followed by diabetes mellitus (31.3%),venous ulcers (16.9%), and sickle cell ulcers (4.8%). Tropical ulcers and others like vasculitis and chronic osteomyelitis accounted for 13.3%. The ulcers have deleterious effects on the patients’ occupation, finances, mobility and social interaction with negative self-image. All the symptoms assessed significantly correlated with overall quality of life (QoL). However, physical symptoms dimension is the most highly correlated with QoL score, followed by social life dimension. The least correlated is wellbeing dimension. Symptoms associated with chronic leg ulcer tend to have negative impact on quality of life of these patients. Therefore, these should be borne in mind and incorporated in the management of these patients.

Validation of the Dutch translation of the Cardiff wound impact schedule for evaluation of the health-related quality of life of patients with chronic wounds.

The aim of this study was to validate a Dutch translation of the Cardiff wound impact schedule (CWIS), a disease‐specific instrument to measure the health‐related quality of life (HRQoL) in patients with chronic leg ulcers. To achieve this, the original instrument was translated. A total of 83 patients with chronic lower leg ulcers were included and completed the translated instrument and SF36 at baseline after assessment of their wound severity. Follow‐up was performed 1 week after inclusion. The psychometric properties of the instrument were assessed. Construct validity was positively evaluated by an expert panel. Face validity was positively evaluated in a cognitive debriefing of a pilot group. Discriminant validity was assessed by correlating 1‐year amputation risk according to the Wound, Ischaemia, foot Infection classification system with the instrument scores. Significant correlation could not be proven. Criterion validity was assessed by correlating domain scores of the instrument with domain scores of the gold standard: SF36. Moderate to high correlation was calculated for most domains of the instrument. Test‐retest reliability and internal consistency were evaluated as acceptable. In conclusion, the Dutch translation of the CWIS is a valid and reliable disease‐specific instrument to assess the HRQoL in patients with chronic lower leg ulcers.

Translation, cross-cultural adaptation and validation of the "Cardiff wound impact schedule," a wound-specific quality of life instrument, to the native Spanish of Mexican patients.

The aim of this study was to translate into Mexican Spanish, cross-culturally adapt and validate the wound-specific quality of life (QoL) instrument Cardiff wound impact schedule (CWIS) for Mexican patients. This instrument went through the full linguistic translation process based on the guidelines of Beaton et al (Beaton DE, Bombardier C, Guillemin F, Ferraz MB, Guidelines for the process of cross-cultural adaptation of self-report measures, Spine Phila Pa, 1976, 2000, 318-391). We included a total of 500 patients with chronic leg ulcers. The expert committee evaluated the Face validity and they agreed unanimously that the instrument was adequate to assess the QoL of these patients, covering all relevant areas presented by them. The content validity index obtained was of 0.95. The construct validity demonstrated moderately significant correlations between related sub-scales of CWIS and SF-36 (P = .010 to P < .001). The instrument was able to discriminate between healed and unhealed ulcers. The instrument obtained an overall Cronbach's alpha of .952, corresponding to an excellent internal consistency (.903-.771 alpha range for domains). The CWIS can be appropriately used to assess the health-related QoL of Mexican patients with chronic leg ulcers.

Capacidade funcional e qualidade de vida de pacientes com feridas crônicas

Objective: To evaluate functional capacity and quality of life (QoL) of patients with chronic wounds. Methods: A cross-sectional analytical study composed of 74 patients with chronic wounds accompanied at a reference center for the treatment of complex wounds in Teresina, state of Piaui. Data were collected using the Katz index and the Cardiff Wound Impact Schedule. Results: Among the domains, the “well-being” had a lower mean score and the degree of dependence obtained a significant association with the well-being and “social life” domains. The bathing, dressing, personal hygiene and locomotion activities showed an association between the domains of QoL. Conclusion: The degree of independence in performing the basic activities of daily living, especially bathing, dressing and personal hygiene, presented higher scores between domains, indicating a better QoL. It is expected that the implantation of measures that help to preserve the functional capacity will improve the patients’ QoL.

Functional capacity and quality of life of patients with chronic wounds

Objective: To evaluate functional capacity and quality of life (QoL) of patients with chronic wounds. Methods: A cross-sectional analytical study composed of 74 patients with chronic wounds accompanied at a reference center for the treatment of complex wounds in Teresina, state of Piaui. Data were collected using the Katz index and the Cardiff Wound Impact Schedule. Results: Among the domains, the “well-being” had a lower mean score and the degree of dependence obtained a significant association with the well-being and “social life” domains. The bathing, dressing, personal hygiene and locomotion activities showed an association between the domains of QoL. Conclusion: The degree of independence in performing the basic activities of daily living, especially bathing, dressing and personal hygiene, presented higher scores between domains, indicating a better QoL. It is expected that the implantation of measures that help to preserve the functional capacity will improve the patients’ QoL.

Evaluation of fluorescence biomodulation in the real-life management of chronic wounds: the EUREKA trial.

Fluorescence biomodulation (FB), a form of photobiomodulation (PBM) that is also known as low energy level light (LELL), has become an increasingly used clinical tool to induce wound healing in wounds that remain recalcitrant to treatment. In a real-life clinical setting, the aim of the EUREKA (EvalUation of Real-lifE use of Klox biophotonic system in chronic wound mAnagement) study was to confirm the efficacy and safety of LumiHeal, a system based on FB, in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs) and pressure ulcers (PUs). The effects of this FB system on the modulation of wound healing in chronic ulcers through FB induction were previously examined in an interim analysis of this study. A multicenter, prospective, observational, uncontrolled trial in 12 clinical sites in Italy. The wound was cleansed with saline and a 2mm thick layer of a chromophore gel was applied to the affected area in a biweekly regimen. The area was then illuminated with the LED activator for five minutes at a distance of 5cm. Treatment was used in combination with standard of care specific to each type of chronic wound (VLU, DFU, PU). Wound area evaluation was assessed using the Silhouette Imaging System and quality of life (QoL) with the Cardiff Wound Impact Schedule (CWIS). A seven-point evaluation of the clinicans' view was also examined. We enrolled 100 subjects, with the final analysis including 99 patients/ulcers consisting of 52 VLUs, 32 DFUs and 15 PUs. Total wound closure at the end of the study was achieved in 47 patients by aetiology: 26 VLUs (50% of VLUs); 16 DFUs (50% of DFUs); and five PUs (33.3% of PUs). The mean wound area regression at last study assessment was significant for VLUs (41.0%; p<0.001) and DFUs (52.4%; p<0.001). After four weeks of treatment, it was possible to significantly predict if the ulcer would respond (defined as a decrease of wound size) to the study treatment. Adherence was high (95.2%) and no related serious adverse events were reported during the study. QoL significantly improved, with an increase of 15.4% of the total score, using the CWIS (p<0.001). The study confirmed a positive efficacy profile of the FB system in inducing the wound healing process in three different types of hard-to-heal chronic wounds. The treatment was shown to be safe and well tolerated by the patients, with a significant improvement in patient QoL. This approach offers an effective modality for the treatment of hard-to-heal chronic ulcers.

Translation and validation of the Chinese powerlessness assessment tool.

The objectives of this study were to translate the powerlessness assessment tool (PAT) into Chinese, and to evaluate its psychometric performance. The PAT was translated into Chinese and was evaluated in patients with chronic wounds. Mean PAT scores were compared between various wound types to evaluate the scale's power to differentiate wound severity (PUSH score). There were 154 consecutive patients included in this study. All items were included, and the results of item-domain correlation (r ranged from 0.838 to 0.967) and small-group analysis (critical ratio, p < 0.05) were satisfactory. Furthermore, the Chinese PAT also showed good criterion validity when correlated with the Cardiff wound impact schedule (r = 0.726, p < 0.01). Exploratory factor analysis of these items extracted only two domains instead of the hypothesized three domains: self-perception of behavioral control and decision making (9 items) and emotional responses to perceived control (3 items), explained 82.045% of the variance. Sensitivity was demonstrated between patients with different activity of daily living, wound severity (PUSH score) and wound types. The internal consistency of all scales of the Chinese PAT was consistently high (Cronbach's alpha ranged from 0.939 to 0. 965) and split-half reliability was 0.901. In conclusion, the validated Chinese PAT has good psychometric properties, and may be used to objectively evaluate the powerlessness experience of Chinese patients with chronic wounds.

The financial and quality‐of‐life cost to patients living with a chronic wound in the community

Chronic wounds are associated with financial and personal costs. The system level expense associated with chronic wounds has been established, however, the out-of-pocket cost incurred by individuals who self-fund has not been the focus of extensive investigation. Recently, there has been renewed interest in evaluating quality of life, in line with the shift to patient enablement and self-care in chronic disease management. The objectives of this research were to describe the out-of-pocket wound treatment costs and the quality of life of people who have chronic wounds. A questionnaire incorporating the Cardiff Wound Impact Schedule and purpose-designed instruments was completed by a non-probability, convenience sample of 113 people in Australia and Wales. Data was analysed using descriptive statistics. The sample was on average 63·6 years of age and had wounds that were on an average 109 weeks duration. Participants had spent on average AU$2475 on wound dressing products since the wound started, and AU$121·82 in the most recent 28 days which represented 10% of their disposable income. Health-related quality of life was sub-optimal, 6/10 (ave) according to the Cardiff Wound Impact Schedule. Younger participants reported significantly poorer quality of life on all CWIS sub-scales when compared to older participants. This study found that chronic wounds present a significant financial cost to individuals who must self-fund their wound dressings and other wound treatment related expenses. Participants who had access to wound product subsidisation also experienced personal financial costs. People who have chronic wounds experience sub-optimal quality of life therefore this condition is also costly to the individual's well-being. The quality of life of younger people has not received adequate attention and requires further consideration given the many years that younger people may have to live with this debilitating and often recurrent condition. Continued action is required to reduce the financial and personal costs experienced by people who have chronic wounds. It is imperative that healthcare funding is directed to people who have chronic wounds, in particular to alleviate the out-of-pocket costs experienced by self-funders. Continued attention to the quality of life of people who have chronic wounds is required to minimise the negative effects of this condition and enhance well-being.

Translation and cross-cultural adaptation of the Cardiff Wound Impact Schedule to Brazilian Portuguese

AimTo translate into Brazilian Portuguese and cross-culturally adapt the Cardiff Wound Impact Schedule, a specific measure of health-related quality of life (HRQoL) for patients with chronic wounds. Chronic wounds have a relevant impact on the HRQoL of patients. However, there are few instruments cross-culturally adapted and validated in Brazil to assess HRQoL in patients with wounds. MethodsA descriptive cross-sectional study was conducted following six steps: (1) translation of the original instrument into Brazilian-Portuguese by two independent translators; (2) construction of a consensus version based on both translations; (3) two independent back-translations into English of the consensus version; (4) review by an expert committee and construction of the pre-final version; (5) testing of the pre-final version on patients with chronic wounds; and (6) construction of the final version. The psychometric properties of the instrument were tested on 30 patients with chronic wounds of the lower limb; 76.7% were men, 70.0% had traumatic wounds, and 43.3% had the wound for more than 1 year. Participants were recruited from an outpatient wound care clinic in São Paulo, Brazil. ResultsThe final version approved by the expert committee was well understood by all patients who participate in the study and had satisfactory face validity, content validity, and internal consistency, with Cronbach's alpha coefficients ranging from 0.681 to 0.920. ConclusionThe cross-culturally adapted Brazilian-Portuguese version of the instrument showed satisfactory face and content validity, good internal consistency, and was named Cardiff Wound Impact Schedule-Federal University of São Paulo School of Medicine or CWIS-UNIFESP/EPM.

Validation of Sinhala Version of Cardiff Wound Impact Schedule in Patients with Diabetic Leg and Foot Ulcers

To validate the Cardiff Wound Impact Schedule (CWIS) to assess the health-related quality of life (HRQoL) of Sri Lankan patients with diabetic leg and foot ulcers. English version of CWIS was examined for cultural compatibility, translated into Sinhala and pretested. The Sinhala version was administered in parallel with the validated Sinhala version of SF-36 by an interviewer to all patients (n= 140) at baseline to determine the construct validity. Reliability of CWIS was measured by internal consistency and test-retest stability. The instrument was readministered in 2 weeks on 33 patients with nonhealing ulcers to determine the test-retest stability and in 3 months on 50 patients with healed ulcers to determine the ability of CWIS to discriminate HRQoL between patients with healed versus nonhealed ulcers. Acceptability of CWIS was assessed by the response rate, completion rate and the average time taken to complete a single interview. The construct validity demonstrated moderately significant correlations between related subscales of CWIS and SF-36 (Spearman's r= .32-.51, p= .021 to p < .001) for the whole study sample. Internal consistencies (Cronbach α= .68-.86) and test-retest stability (.56-.70) were acceptable. The tool was sensitive in discriminating the impact of the wound on HRQoL in healed versus nonhealed status (p ≤ .001). The tool showed good acceptability. The Sinhala version of CWIS is valid, reliable and acceptable for assessing the impact of wound on HRQoL. This instrument is sensitive in detecting the differences of the impact of healed and nonhealed ulcers on QoL in patients with diabetic leg and foot ulcer.

Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial.

BackgroundUlcers of the heel in diabetes are the source of considerable suffering and cost. In the absence of specific treatments, it has been suggested that removable, lightweight fibreglass heel casts may both promote healing and reduce discomfort and pain. The aim of the study is to assess the effectiveness and cost-effectiveness of fibreglass heel casts in the management of heel ulcers.Methods/DesignThis is an observer-blind, randomised controlled trial in which participants with diabetes and heel ulcers (NPUAP/EPUAP grades 2, 3 or 4 and present for 2 or more weeks) are randomised to receive either usual care plus lightweight fibreglass heel casts or usual care alone. Randomisation is undertaken by random number sequence generation incorporated as part of the electronic case record form, and is stratified by both ulcer area (less than versus equal to or greater than 1 cm2) and NPUAP/EPUAP grade. Participants are followed every two weeks until healing or for 24 weeks. The primary outcome measure is healing at or before 24 weeks and maintained for 4 weeks. Secondary outcomes include (i) ulcer-related outcomes: time to healing, change in ulcer area, minor and major amputation, secondary infection and (ii) patient-related outcomes: local pain, mood and function (EQ-5D), impact of the ulcer (Cardiff Wound Impact Schedule) and survival. Cost-effectiveness will be assessed using a decision analytic model to estimate costs from the perspective of the UK NHS and personal social services and health outcomes, including percent healing and Quality Adjusted Life Years gained.Safety will be documented as adverse and serious adverse device effects.DiscussionIf it is possible to confirm significant clinical benefit and/or cost-effectiveness, this would have direct implications for the management of this distressing and costly complication of diabetesTrial registration numberISRCTN62524796 Registered 29 March 2011

The “Wound‐QoL”: A short questionnaire measuring quality of life in patients with chronic wounds based on three established disease‐specific instruments

The aim of this study was to develop a short questionnaire measuring health-related quality of life (HRQoL) in chronic wounds. Three validated instruments assessing HRQoL in chronic wounds-the Freiburg Life Quality Assessment for wounds, the Cardiff Wound Impact Schedule, and the Würzburg Wound Score-were completed by 154 German leg ulcer patients in a longitudinal study. For implementation in the new, shorter questionnaire Wound-QoL, all of those 92 items that covered the core content of the three questionnaires and showed good psychometric properties were selected. Internal consistency, convergent validity, and responsiveness were analyzed using the study data on the selected items (a new approach called virtual validation). Subscales were determined with factor analysis. Item, instruction, and response scale wording were harmonized. Seventeen items were included in the Wound-QoL, which could be attributed to three subscales on everyday life, body, and psyche. Both global score and subscale scores were internally consistent with Cronbach's alpha between 0.71 and 0.91. The global score showed significant convergent validity (r = 0.48 to 0.69) and responsiveness (r = 0.18 to 0.52); the same was true for the subscale scores. The Wound-QoL for measurement of HRQoL in chronic wounds proved to be internally consistent, valid, and responsive in German leg ulcer patients. The findings of this virtual validation study need to be confirmed in a longitudinal validation study on the final Wound-QoL, which is currently being conducted.