Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Periph… (NCT06495424) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy
United States144 participantsStarted 2025-03-14
Plain-language summary
The purpose of this post-market observational study is to provide real-world evidence to support the repeated use of QUTENZA in patients with PDPN and to evaluate the potential for pain and concomitant medication use reduction.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. IRB approved written Informed Consent and privacy language as per national regulations will be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)
✓. Male or female 18 - 80 years of age
✓. Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy due to diabetes confirmed by the Douleur Neuropathique 4 Interview (DN4I) of at least 3 out of 7
✓. Baseline PROMIS-29 numeric pain intensity score over the last 7 days ≥ 4 during the screening period
✓. Stable doses of pain medications for PDPN for more than 4 weeks prior to the screening visit
✓. Patient agreed not to participate in another interventional study while on treatment
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
What they're measuring
1
Change (%) in pain intensity post QUTENZA administrations
Timeframe: Baseline, weeks 2-12 Post-Admin
2
Change (%) in overall scores for Patient-Report Outcomes Measurement Information System (PROMIS)-29
Timeframe: Baseline, week 12 Post-Admin
3
Total number of patients who completed each QUTENZA treatment.
Timeframe: week 12 Post-Admin
4
Change (%) of concomitant medications at baseline and 12 weeks after each treatment
Timeframe: through study completion, an average of 36 weeks