Adaptation and Validation of the Diabetic Foot Ulcer Scale-Short Form in Spanish Subjects

Diabetic foot ulcer (DFU) is a chronic complication that negatively affects the quality of life (QoL) of diabetic patients. In Spain, there is no specifically designed and validated instrument to assess the QoL of patients with DFU. Our aim was to adapt the Diabetic Foot Ulcer Scale-Short Form (DFS-SF) questionnaire to a Spanish population and validate it. A prospective, observational design was used. The DFS-SF was administered by personal interview. The validated SF-36 and EQ-5D generic instruments were used as reference tools. The reliability, validity, and sensitivity to changes were assessed using standard statistical methods. A sample of 141 patients with DFU was recruited. The content validity was 3.46 on average (maximum score of 4). The internal consistency of the DFS-SF subscales showed a standardized Cronbach’s α range between 0.720 and 0.948. The DFS-SF domains showed excellent reproducibility measures (intraclass correlation coefficient from 0.77–0.92). The criterion validity was good with significant correlations between each DFS-SF subscale and its corresponding SF-36 and EQ-5D subscales (p < 0.001). However, the questionnaire structure was not validated (comparative fit index = 0.844, root mean square error of approximation = 0.095, and standardized root mean square residual = 0.093). The instrument showed high sensitivity to ulcer changes over time (p < 0.001). The adapted and validated Spanish version of the DFS-SF questionnaire has good psychometric properties and shows good sensitivity to ulcer changes, although the construct validity was not optimal. The adapted questionnaire will be a useful tool specifically to assess the QoL in subjects with diabetic foot ulcers in the clinical and research settings in Spain.CIBERDEM is an initiative from Instituto de Salud Carlos III (Plan Nacional de I + D + I and Fondo Europeo de Desarrollo Regional). M.G.-C. held a predoctoral fellowship from the Ministerio de Educación, Cultura y Deporte, FPU15/03005. This project was developed in the context of the Programme “Doctorat en Medicina de la Universitat Autònoma de Barcelona”, Autonomous University of Barcelona

Adaptation and Validation of the Diabetic Foot Ulcer Scale-Short Form in Spanish Subjects

Diabetic foot ulcer (DFU) is a chronic complication that negatively affects the quality of life (QoL) of diabetic patients. In Spain, there is no specifically designed and validated instrument to assess the QoL of patients with DFU. Our aim was to adapt the Diabetic Foot Ulcer Scale-Short Form (DFS-SF) questionnaire to a Spanish population and validate it. A prospective, observational design was used. The DFS-SF was administered by personal interview. The validated SF-36 and EQ-5D generic instruments were used as reference tools. The reliability, validity, and sensitivity to changes were assessed using standard statistical methods. A sample of 141 patients with DFU was recruited. The content validity was 3.46 on average (maximum score of 4). The internal consistency of the DFS-SF subscales showed a standardized Cronbach’s α range between 0.720 and 0.948. The DFS-SF domains showed excellent reproducibility measures (intraclass correlation coefficient from 0.77–0.92). The criterion validity was good with significant correlations between each DFS-SF subscale and its corresponding SF-36 and EQ-5D subscales (p < 0.001). However, the questionnaire structure was not validated (comparative fit index = 0.844, root mean square error of approximation = 0.095, and standardized root mean square residual = 0.093). The instrument showed high sensitivity to ulcer changes over time (p < 0.001). The adapted and validated Spanish version of the DFS-SF questionnaire has good psychometric properties and shows good sensitivity to ulcer changes, although the construct validity was not optimal. The adapted questionnaire will be a useful tool specifically to assess the QoL in subjects with diabetic foot ulcers in the clinical and research settings in Spain.CIBERDEM is an initiative from Instituto de Salud Carlos III (Plan Nacional de I + D + I and Fondo Europeo de Desarrollo Regional). M.G.-C. held a predoctoral fellowship from the Ministerio de Educación, Cultura y Deporte, FPU15/03005. This project was developed in the context of the Programme “Doctorat en Medicina de la Universitat Autònoma de Barcelona”, Autonomous University of Barcelona

High Incidence of Adverse Outcomes in Haemodialysis Patients with Diabetes with or without Diabetic Foot Syndrome: A 5-Year Observational Study in Lleida, Spain

Background: We evaluated whether, in subjects receiving haemodialysis (HD), the presence of diabetic foot syndrome (DFS) was associated with increased mortality compared with subjects with diabetes mellitus (DM) without DFS and with non-diabetic subjects. Methods: Retrospective, observational study in 220 subjects followed for six years. We calculated and compared the frequency and 5-year cumulative incidence of all-cause mortality, cardiovascular (CV) mortality, CV events, major adverse CV events (MACE), and new foot ulcer (FU) or amputation. We also examined prognostic factors of all-cause and CV mortality based on baseline characteristics. Results: DM patients had a 1.98 times higher probability of all-cause mortality than those without DM (p = 0.001) and 2.42 times higher likelihood of CV mortality and new FU or amputation (p = 0.002 and p = 0.008, respectively). In the DM cohort, only the risk of a new FU or amputation was 2.69 times higher among those with previous DFS (p = 0.021). In patients with DM, older age was the only predictor of all-cause and CV mortality (p = 0.001 and p = 0.014, respectively). Conclusions: Although all-cause and CV mortality were increased on HD subjects with DM, the presence of DFS did not modify the excess risk. Additional studies are warranted to further explore the impact of DFS in subjects with DM undergoing HD

Prevalence of Diabetic Foot Disease in Patients with Diabetes Mellitus under Renal Replacement Therapy in Lleida, Spain

Aim. To assess the prevalence of diabetic foot and other associated conditions in patients with diabetes mellitus under renal replacement in the region of Lleida, Spain. Methods. This was an observational, cross-sectional study of 92 dialysis-treated diabetic patients. Besides a podiatric examination, we explored the presence of cardiovascular risk factors, late diabetes complications, including peripheral neuropathy, atherosclerotic disease, and peripheral artery disease. We assessed risk factors for foot ulceration and amputation by logistic regression. Results. Prevalent diabetic foot was found in 17.4% of patients, foot deformities were found in 54.3%, previous ulcer was found in 19.6%, and amputations were found in 16.3%; and 87% of them had some risk of suffering diabetic foot in the future. We observed a high prevalence of patients with peripheral neuropathy and peripheral artery disease (89.1% and 64.2%, resp.). Multivariable analysis identified diabetic retinopathy and advanced atherosclerotic disease (stenosing carotid plaques) as independent risk factors for foot ulceration (p=0.004 and p=0.023, resp.) and diabetic retinopathy also as an independent risk factor for lower-limb amputations (p=0.013). Moreover, there was a temporal association between the initiation of dialysis and the incidence of amputations. Conclusion. Diabetic patients receiving dialysis therapy are at high risk of foot complications and should receive appropriate and intensive foot care

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.This research was funded by CIBERDEM is an initiative from Instituto de Salud Carlos III (Plan Nacional de I + D + I and Fondo Europeo de Desarrollo Regional). M.G.-C. held a predoctoral fellowship from the Ministerio de Educación, Cultura y Deporte, FPU15/03005

Correction: Martinez-Gonzalez et al. Adaptation and Validation of the Diabetic Foot Ulcer Scale-Short Form in Spanish Subjects. J. Clin. Med. 2020, 9, 2497

In the original publication [...

Prevalence of Diabetic Foot Disease in Patients with Diabetes Mellitus under Renal Replacement Therapy in Lleida, Spain

Aim. To assess the prevalence of diabetic foot and other associated conditions in patients with diabetes mellitus under renal replacement in the region of Lleida, Spain. Methods. This was an observational, cross-sectional study of 92 dialysis-treated diabetic patients. Besides a podiatric examination, we explored the presence of cardiovascular risk factors, late diabetes complications, including peripheral neuropathy, atherosclerotic disease, and peripheral artery disease. We assessed risk factors for foot ulceration and amputation by logistic regression. Results. Prevalent diabetic foot was found in 17.4% of patients, foot deformities were found in 54.3%, previous ulcer was found in 19.6%, and amputations were found in 16.3%; and 87% of them had some risk of suffering diabetic foot in the future. We observed a high prevalence of patients with peripheral neuropathy and peripheral artery disease (89.1% and 64.2%, resp.). Multivariable analysis identified diabetic retinopathy and advanced atherosclerotic disease (stenosing carotid plaques) as independent risk factors for foot ulceration ( = 0.004 and = 0.023, resp.) and diabetic retinopathy also as an independent risk factor for lower-limb amputations ( = 0.013). Moreover, there was a temporal association between the initiation of dialysis and the incidence of amputations. Conclusion. Diabetic patients receiving dialysis therapy are at high risk of foot complications and should receive appropriate and intensive foot care

Prevalence of Diabetic Foot Disease in Patients with Diabetes Mellitus under Renal Replacement Therapy in Lleida, Spain

Aim. To assess the prevalence of diabetic foot and other associated conditions in patients with diabetes mellitus under renal replacement in the region of Lleida, Spain. Methods. This was an observational, cross-sectional study of 92 dialysis-treated diabetic patients. Besides a podiatric examination, we explored the presence of cardiovascular risk factors, late diabetes complications, including peripheral neuropathy, atherosclerotic disease, and peripheral artery disease. We assessed risk factors for foot ulceration and amputation by logistic regression. Results. Prevalent diabetic foot was found in 17.4% of patients, foot deformities were found in 54.3%, previous ulcer was found in 19.6%, and amputations were found in 16.3%; and 87% of them had some risk of suffering diabetic foot in the future. We observed a high prevalence of patients with peripheral neuropathy and peripheral artery disease (89.1% and 64.2%, resp.). Multivariable analysis identified diabetic retinopathy and advanced atherosclerotic disease (stenosing carotid plaques) as independent risk factors for foot ulceration (p=0.004 and p=0.023, resp.) and diabetic retinopathy also as an independent risk factor for lower-limb amputations (p=0.013). Moreover, there was a temporal association between the initiation of dialysis and the incidence of amputations. Conclusion. Diabetic patients receiving dialysis therapy are at high risk of foot complications and should receive appropriate and intensive foot care