Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy

Exclusion criteria

• . Pain associated with PDPN in the ankles or above
• . Pain that could not be clearly differentiated from, or conditions that might have interfered with the assessment of the PDPN, such as plantar fasciitis, heel spurs, tibial neuropathy, Morton's neuroma, bunions, metatarsalgia, arthritis in feet, peripheral vascular disease (ischemic pain), neurological disorders unrelated to diabetic neuropathy (eg, phantom limb pain from amputation), skin condition in the area of the neuropathy that could alter sensation (eg, plantar ulcer)
• . Significant pain (moderate or above) of an etiology other than PDPN (eg, compression-related neuropathies \[eg, spinal stenosis\]), fibromyalgia or arthritis, that may interfere with assessment of PDPN-related pain
• . Current foot ulcer or not intact skin as determined by medical examination
• . Clinically significant foot deformities or foot amputations
• . Any active signs of skin inflammation around onychomycosis sites such as pain, redness, swelling or drainage
• . Patient is unwilling to implement proper foot care methods
• . Diagnosis of any poorly controlled major psychiatric disorder at the Investigator's discretion