title: A Clinical Trial of Nitrosense patch for the treatment of patients with painful diabetic neuropathy.
abstract: OBJECTIVE
  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.
authors.forename: R P
authors.initials: RP
authors.lastname: Agrawal
authors.forename: S
authors.initials: S
authors.lastname: Jain
authors.forename: S
authors.initials: S
authors.lastname: Goyal
authors.forename: S
authors.initials: S
authors.lastname: Singhal
authors.forename: L
authors.initials: L
authors.lastname: Lindgren
authors.forename: E
authors.initials: E
authors.lastname: Sthengel
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy; D017719:Diabetic Foot / Q000188:drug therapy / Q000503:physiopathology; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009569:Nitric Oxide / Q000008:administration & dosage / Q000378:metabolism; D020030:Nitric Oxide Donors / Q000008:administration & dosage*; D061366:Numbers Needed To Treat; D010147:Pain Measurement / Q000187:drug effects; D012684:Sensory Thresholds / Q000187:drug effects; D014732:Vibration
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D020030:Nitric Oxide Donors; C000594696:NitroSense; D009569:Nitric Oxide