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Background:Outcomes in peripheral arterial disease (PAD) are usually clinical alone, ignoring patient´s bio-psychological sphere. VascuQol-6 is a specific questionnaire aimed to asses quality of life of patients suffering PAD. Our objective was to carry out a cross-cultural adaptation and validation of VQ-6 questionnaire from original English version into Spanish, in order to have a rapid, sensitive and easy-to-apply clinical tool for evaluating HRQoL outcomes in PAD patients.MethodsA prospective study with 100 outpatients with PAD patients was carried out in two university hospitals. Patients completed the Spanish translated VasquQol-6 (VQ-6) questionnaire and the SF-12 questionnaire. Validation of the VQ-6 Spanish Version was assessed through statistical measurement of reliability, reproducibility and validity of the questionnaire. Reproducibility of the Spanish VQ-6 was assessed through Intraclass Correlation Coefficient, while Internal consistency was analyzed through Alpha Cronbach. Criterion Validity was assessed by comparing the SF-12 and with Pearson’s Correlation Coefficient. Construct Validity was assessed by comparing the results of the questionnaire with the stage of the PAD based on Rutherford-Becker Category.ResultsOn hundred patients were included in the study from July 2019 to January 2021. 82 % were male with a median age of 71.6 years. The reproducibility of the VQ-6 Spanish Version in each item was evaluated in a sample of 80 patients. Pain, Activity, Social and Emotional domains had ICC values ranging from 0.70 to 0.88, indicating a good agreement. The value obtained for Cronbach's Alpha was 0.89 using all the questions of the questionnaire, indicating a good internal consistency. VQ-6 and SF-12 showed positive correlations. The overall Pearson Correlation Coefficient was 0.77 for Physical SF-12, indicating an elevated Criterion Validity. Under´s curve area was 0.8, so discrimination capacity of VQ-6 Spanish Version to discriminate between IC and CLI was considered good.ConclusionVQ-6 Spanish Version is a reliable and valid instrument for evaluation of quality of life in patients suffering from PAD that can be used in clinical practice, adding a decision-base when evaluating different treatment options. This VQ-6 Spanish Version is intended to cover the spectrum of severity of PAD in Spanish-speaking patients.Trial registration: ClinicalTrials.gov NCT04741321. Retrospectively registered on February 05,2021)

Background: Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. Methods: A multicenter, randomized double-blind, placebo-controlled trial has been designed. 90 eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: the control group (n=30), low cell dose treatment group (n=30), and high cell dose treatment group (n=30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. Discussion: Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future.Trial registration: ClinicalTrials.gov NCT04466007. Registered on January 07, 2020.