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Objective: The use of emollients to lubricate dry skin to prevent diabetic foot ulcers (DFUs), especially in neuroischaemic feet, has been recommended. This study analyses the effect of daily topical application of hyperoxygenated fatty acids emulsion on transcutaneous oxygen pressure (TcPO2) in the feet of neuropathic and neuroischaemic patients with diabetes. Method: Patients with diabetes and no active foot ulcer were included in this longitudinal, prospective, non-comparative clinical trial. The evolution of TcPO2 (mmHg) values after the application of the tested emulsion (Corpitol Emulsion, Laboratoires Urgo Medical, France) was evaluated for a three-month period. Modifications of skin features (skin dryness, skin shedding and skin colour) were also analysed. TcPO2 was performed using a TCM400 device (Radiometer, Denmark). Results: A total of 50 patients were included in the study. Patients with neuroischaemia showed a significant increase in TcPO2 values (35.69±13.88mmHg) after two months' application of the tested emulsion that remained at month three (day 60: 42.34±10.98mmHg; p=0.006; day 90: 41.62±10.88mmHg; p=0.011). Skin dryness and shedding showed an improvement from baseline to the end of the study in both groups, secondary to the use of the tested emulsion (p<0.001 and p<0.001, respectively). Skin colour also showed differences from baseline to the final visit in the neuroischaemic patients (p=0.029). Patients with neuropathy did not show any change in skin colour from baseline to the final visit. Conclusions: Analysis of the use of the tested emulsion showed an increase in TcPO2 and an improvement in skin trophism in patients with neuroischaemic foot. [ABSTRACT FROM AUTHOR]

Background Pressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment. Methods/design The main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student's t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis. Discussion The regular use of olive-oil-based formulas should be effective in preventing pressure ulcers in immobilized patients, thus leading to a more cost-effective product and an alternative treatment. [ABSTRACT FROM AUTHOR]