A Clinical Trial of Nitrosense patch for the treatment of patients with painful diabetic neuropathy.

AIMS

Impaired nitric oxide synthesis has been implicated as one of the underlying causes of diabetic painful neuropathy (DPN). Hence, effects of a cutaneous, nitric oxide releasing patch (NitroSense Derma Protect) were evaluated in subjects with DPN.

METHODS

Fifty diabetics were randomised to active/placebo arms after a 2 wk wash-out period. Patients received 24 mg patches (each patch releases around 9 nmol/cm2/min of nitric oxide) for 3 hrs, every other day during a 3 wks period, or indistinguishable placebo patches. The extent of pain was recorded at start, at each visit and following completion of the study. Changes in pain from baseline were measured using the 11 point lickert scale (PLS), visual analogue scale (VAS), short form mcgill, pain questionnaire (SF-MPQ), present pain intensity (PPI) scale.

RESULTS

Subjects treated with patch experienced a statistically significant reduction in pain from baseline when compared to placebo (PLS scale; p = 0.05). Defining responders as subjects with a > 50% reduction in PLS score from baseline, the number needed to treat (NNT) was calculated as 3.0. A significant post-treatment decrease (p = 0.009) in vibration perception threshold (VPT) for left foot after active treatment was observed.

CONCLUSIONS

Present results highlight utility of NitroSense Derma Protect as controllable nitric oxide source for patients with DPN.