Efficacy and safety of neutral pH superoxidised solution in severe diabetic foot infections

Abstract

The use of antiseptics in wound care is often controversial and there is definitely a need for a non toxic, highly disinfective agent. This study assessed the efficacy of a neutral pH superoxidised aqueous solution (NpHSS) for infection control, odour reduction and surrounding skin and tissue damage on infected diabetic foot ulcerations. From November 2003 to March 2004, 45 patients with type 2 diabetes were randomised into a single-blind clinical trial comparing NpHSS (intervention group; n = 21) versus conventional disinfectant (control group; n = 16). All patients received comprehensive care including surgical debridement as appropriate, moist wound care, intensive glucose control and broad spectrum antibiotics. Treatment groups were matched in terms of sex, age (61.9 +/- 11.9 versus 67.8 +/- 11.6), years of diabetes duration (16.4 +/- 8.1 versus 17 +/- 10.2), obesity, HgAlc (7.1 +/- 2 versus 6.7 +/- 1.8), initial fasting glycaemia (163 +/- 59 versus 152 +/- 65.8 mg/dl), ulcer duration/week (13.7 +/- 24 versus 15.1 +/- 16.3), B/A Index (0.9 +/- 0.5 versus 1.14 +/- 0.7), depth and extent of infection/periwound cellulitis (groups B and C of the Tampico Hospital Classification) as well as aetiology (P = 0.647). Odour reduction was achieved in all NpHSS patients (100% versus 25%; P < 0.01) and surrounding cellulitis diminished (P < 0.001) in 17 patients (80.9% versus 43.7%). Nineteen patients in the NpHSS group showed advancement to granulating tissue stage (90.4% versus 62.5%; P = 0.05) with significantly less tissue toxicity (94% versus 31.2%; P < 0.01). A non toxic, NpHSS, as part of a comprehensive care regimen, may be more efficacious in infection control, odour and erythema reduction than conventional disinfectants in treatment of diabetic foot infections.

Figure 1

Oxidative stress and body primary and secondary defences. HOCl, hypochlorous acid; ILK‐1, interleukin‐1; MPO, myeloperoxidase; NpHSS, neutral pH superoxidised aqueous solution; NTF, necrosis tumor factor; ROI, reactive oxygen intermediates; ROS, reactive oxygen species; RNI, reactive nitrogen intermediates; VEGF, vascular endothelial growth factor.

Figure 2

A 48‐year‐old woman with severe diabetic foot infection condemned previously to our assessment for below‐knee amputation. Left picture shows the patient foot at initial surgical debridement. Fetid odour, necrosis, cellulitis area of more than 10 cm deep abscess, necrotic injuries and ‘browned’ coloured purulent discharge were present. Right picture shows 2–3 weeks later that granulating tissue increased and improving of skin condition around ulcer after neutral pH superoxidised aqueous solution treatment.

Figure 3

Nine weeks later, after use of neutral pH superoxidised aqueous solution. Granulating tissue, wound contraction and healthy skin around the ulcer. Right picture shows total wound healing in a patient visit 4 months later.