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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Painful Diabetic Neuropathy; Peripheral Diabetic Neuropathy
• Intervention / Treatment: Drug: Capsaicin 8%

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19808
      • Center for Interventional Pain and Spine
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Horizon Clinical Research
    • Jasper, Georgia, United States, 30143
      • Horizon Clinical Research
    • Newnan, Georgia, United States, 30265
      • Horizon Clinical Research
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Iqra Research
  • New Jersey
    • Oradell, New Jersey, United States, 07649
      • Curalta Clinical Trials
  • Ohio
    • Cincinnati, Ohio, United States, 45248
      • Iqra Research
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Center for Interventional Pain and Spine
    • Fort Washington, Pennsylvania, United States, 19034
      • Center for Interventional Pain and Spine
    • Lancaster, Pennsylvania, United States, 17601
      • Center for Interventional Pain and Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients for inclusion in the study are those with PDPN as assessed by the Douleur Neuropathique 4 Interview (DN4I) assessment.

Description

Inclusion 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

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 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; All subjects will receive repeat applications of the capsaicin 8% topical system every 12 weeks (up to 3 applications).	Drug: Capsaicin 8%; Repeat applications every 12 weeks in patients with PDPN of the feet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (%) in pain intensity post QUTENZA administrations	The pain intensity score from baseline will be compared to the average weekly pain intensity score between weeks 2-12 post each QUTENZA application (up to 3 applications).	Baseline, weeks 2-12 Post-Admin
Change (%) in overall scores for Patient-Report Outcomes Measurement Information System (PROMIS)-29	The baseline PROMIS-29 scores for all domains will be compared to the PROMIS-29 scores assessed at 12 weeks post-each QUTENZA application (up to 3 applications).	Baseline, week 12 Post-Admin
Total number of patients who completed each QUTENZA treatment.	Analysis of the number of patients who completed repeated (2 or 3) QUTENZA applications.	week 12 Post-Admin
Change (%) of concomitant medications at baseline and 12 weeks after each treatment	The change in utilization of pharmaceutical drug by medication, pharmacology class, dose, and frequency of use for drugs for PDPN, documented by collecting Concomitant medications including indication (for PDPN, for other reasons, and for temporary rescue use for PDPN) and dose	through study completion, an average of 36 weeks

Collaborators and Investigators

• Sponsor: Averitas Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Complications; Diabetic Neuropathies; Organic Chemicals; Heterocyclic Compounds; Fatty Acids; Lipids; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Hydrocarbons, Cyclic; Alkaloids; Hydrocarbons, Aromatic; Amides; Catechols; Phenols; Benzene Derivatives; Fatty Acids, Unsaturated; Solanaceous Alkaloids; Polyunsaturated Alkamides; Fatty Acids, Monounsaturated; Capsaicin
• Other Study ID Numbers: AV002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No