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

Inclusion Criteria:

1. IRB approved written Informed Consent and privacy language as per nationalregulations will be obtained from the patient or legally authorized representativeprior to any study-related procedures (including withdrawal of prohibitedmedication, if applicable)

2. Male or female 18 - 80 years of age

3. Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy due todiabetes confirmed by the Douleur Neuropathique 4 Interview (DN4I) of at least 3 outof 7

4. Baseline PROMIS-29 numeric pain intensity score over the last 7 days ≥ 4 during thescreening period

5. Stable doses of pain medications for PDPN for more than 4 weeks prior to thescreening visit

6. Patient agreed not to participate in another interventional study while on treatment

Exclusion Criteria:

1. Pain associated with PDPN in the ankles or above

2. Pain that could not be clearly differentiated from, or conditions that might haveinterfered 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 todiabetic neuropathy (eg, phantom limb pain from amputation), skin condition in thearea of the neuropathy that could alter sensation (eg, plantar ulcer)

3. 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

4. Current foot ulcer or not intact skin as determined by medical examination

5. Clinically significant foot deformities or foot amputations

6. Any active signs of skin inflammation around onychomycosis sites such as pain,redness, swelling or drainage

7. Patient is unwilling to implement proper foot care methods

8. Diagnosis of any poorly controlled major psychiatric disorder at the Investigator'sdiscretion

9. Evidence of cognitive impairment including dementia that may interfere withpatient's ability to complete pain assessments requiring patient's recall of averagepain level in the past 24 hours

10. Active substance abuse or history of chronic substance abuse within 1 year prior toscreening visit or any prior chronic substance abuse (including alcoholism) likelyto have reoccurred during the study period as judged by the Investigator

11. Participation in any other PDPN related clinical study within 30 days prior to thescreening visit

12. Previous treatment with QUTENZA

13. Hypersensitivity to capsaicin (eg, chili peppers or over-the-counter capsaicinproducts) or any QUTENZA excipients

14. Active malignancy or history of malignancy during the past 5 years prior toscreening visit (a history of squamous cell carcinoma or a basal cell carcinoma notinvolving the area to be treated is allowed)

15. Use of transcutaneous nerve or spinal cord stimulators to relieve pain

16. Patient, who in the opinion of the Investigator, is not likely to complete the studyfor any reason