RECRUITING

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

Conditions

Peripheral Diabetic Neuropathy Painful Diabetic Neuropathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-14

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06495424

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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) 2. Male or female 18 - 80 years of age 3. 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 4. Baseline PROMIS-29 numeric pain intensity score over the last 7 days ≥ 4 during the screening period 5. Stable doses of pain medications for PDPN for more than 4 weeks prior to the screening visit 6. Patient agreed not to participate in another interventional study while on treatment	1. Pain associated with PDPN in the ankles or above 2. 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) 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's discretion 9. Evidence of cognitive impairment including dementia that may interfere with patient's ability to complete pain assessments requiring patient's recall of average pain level in the past 24 hours 10. Active substance abuse or history of chronic substance abuse within 1 year prior to screening visit or any prior chronic substance abuse (including alcoholism) likely to 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 the screening visit 12. Previous treatment with QUTENZA 13. Hypersensitivity to capsaicin (eg, chili peppers or over-the-counter capsaicin products) or any QUTENZA excipients 14. Active malignancy or history of malignancy during the past 5 years prior to screening visit (a history of squamous cell carcinoma or a basal cell carcinoma not involving 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 study for any reason

Inclusion Criteria

Exclusion Criteria

1. 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)
2. Male or female 18 - 80 years of age
3. 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
4. Baseline PROMIS-29 numeric pain intensity score over the last 7 days ≥ 4 during the screening period
5. Stable doses of pain medications for PDPN for more than 4 weeks prior to the screening visit
6. Patient agreed not to participate in another interventional study while on treatment

1. Pain associated with PDPN in the ankles or above
2. 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)
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's discretion
9. Evidence of cognitive impairment including dementia that may interfere with patient's ability to complete pain assessments requiring patient's recall of average pain level in the past 24 hours
10. Active substance abuse or history of chronic substance abuse within 1 year prior to screening visit or any prior chronic substance abuse (including alcoholism) likely to 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 the screening visit
12. Previous treatment with QUTENZA
13. Hypersensitivity to capsaicin (eg, chili peppers or over-the-counter capsaicin products) or any QUTENZA excipients
14. Active malignancy or history of malignancy during the past 5 years prior to screening visit (a history of squamous cell carcinoma or a basal cell carcinoma not involving 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 study for any reason

Contacts and Locations

Study Contact

Medical Information

CONTACT

0000000000

medinfo@averitaspharma.com

Medical Information

CONTACT

medinfo@averitaspharma.com

Study Locations (Sites)

Pacific Research Institute

Lakeport, California, 95453

United States

Pacific Research Institute

Santa Rosa, California, 95404

United States

Pacific Research Institute

Santa Rosa, California, 95407

United States

Pacific Research Institute

Sonoma, California, 95476

United States

Center for Interventional Pain and Spine

Wilmington, Delaware, 19808

United States

Horizon Clinical Research

Gainesville, Georgia, 30501

United States

Horizon Clinical Research

Jasper, Georgia, 30143

United States

Horizon Clinical Research

Newnan, Georgia, 30265

United States

Iqra Research

Edgewood, Kentucky, 41017

United States

Curalta Clinical Trials

Oradell, New Jersey, 07649

United States

Center for Interventional Pain and Spine

Bryn Mawr, Pennsylvania, 19010

United States

Center for Interventional Pain and Spine

Fort Washington, Pennsylvania, 19034

United States

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, 17601

United States

Collaborators and Investigators

Sponsor: Averitas Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-14

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-03-14

Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

Peripheral Diabetic Neuropathy
Painful Diabetic Neuropathy