A Post-Market Observational Multi-Center Study to Evaluate the Effectiveness of Repeated QUTENZA Use in Adults With Painful Diabetic Peripheral Neuropathy of the Feet
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Pacific Research Institute
RECRUITING
Lakeport
Pacific Research Institute
RECRUITING
Santa Rosa
Pacific Research Institute
RECRUITING
Santa Rosa
Pacific Research Institute
RECRUITING
Sonoma
Delaware
Center for Interventional Pain and Spine
RECRUITING
Wilmington
Georgia
Horizon Clinical Research
RECRUITING
Gainesville
Horizon Clinical Research
RECRUITING
Jasper
Horizon Clinical Research
RECRUITING
Newnan
Kentucky
Iqra Research
RECRUITING
Edgewood
New Jersey
Curalta Clinical Trials
RECRUITING
Oradell
Pennsylvania
Center for Interventional Pain and Spine
RECRUITING
Bryn Mawr
Center for Interventional Pain and Spine
RECRUITING
Fort Washington
Center for Interventional Pain and Spine
RECRUITING
Lancaster
Contact Information
Primary
Medical Information
medinfo@averitaspharma.com
0000000000
Backup
Medical Information
medinfo@averitaspharma.com
Time Frame
Start Date:2025-03-14
Estimated Completion Date:2027-03
Participants
Target number of participants:150
Treatments
Study group
All subjects will receive repeat applications of the capsaicin 8% topical system every 12 weeks (up to 3 applications).