Evolution of the TcPO2 values following hyperoxygenated fatty acids emulsion application in patients with diabetic foot disease: results of a clinical trial

Abstract

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.