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

NCT06495424 | Active Not Recruiting FDA Drug

• 1 other identifier: AV002
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Painful Diabetic Neuropathy; Peripheral Diabetic Neuropathy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Study group

All subjects will receive repeat applications of the capsaicin 8% topical system every 12 weeks (up to 3 applications).

Drug: Capsaicin 8%

Interventions

Capsaicin 8% DRUG

Repeat applications every 12 weeks in patients with PDPN of the feet.

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Current foot ulcer or not intact skin as determined by medical examination
• Clinically significant foot deformities or foot amputations
• Any active signs of skin inflammation around onychomycosis sites such as pain, redness, swelling or drainage
• Patient is unwilling to implement proper foot care methods
• Diagnosis of any poorly controlled major psychiatric disorder at the Investigator's discretion
• 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
• 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
• Participation in any other PDPN related clinical study within 30 days prior to the screening visit
• Previous treatment with QUTENZA
• Hypersensitivity to capsaicin (eg, chili peppers or over-the-counter capsaicin products) or any QUTENZA excipients
• 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)
• Use of transcutaneous nerve or spinal cord stimulators to relieve pain

Sponsors & Collaborators

• Averitas Pharma, Inc.: lead

Study Sites (10)

Center for Interventional Pain and Spine

Wilmington, Delaware, 19808, United States

Location

Horizon Clinical Research

Gainesville, Georgia, 30501, United States

Location

Horizon Clinical Research

Jasper, Georgia, 30143, United States

Location

Horizon Clinical Research

Newnan, Georgia, 30265, United States

Location

Iqra Research

Edgewood, Kentucky, 41017, United States

Location

Curalta Clinical Trials

Oradell, New Jersey, 07649, United States

Location

Iqra Research

Cincinnati, Ohio, 45248, United States

Location

Center for Interventional Pain and Spine

Bryn Mawr, Pennsylvania, 19010, United States

Location

Center for Interventional Pain and Spine

Fort Washington, Pennsylvania, 19034, United States

Location

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, 17601, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 10, 2024
• Study Start: March 14, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (10)