Peripheral Diabetic NeuropathyNCT06495424
Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy
An observational study of Peripheral Diabetic Neuropathy and Painful Diabetic Neuropathy, run by Averitas Pharma, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Diabetic Neuropathy, Painful Diabetic Neuropathy
- What is being tested?
- Capsaicin 8%
- How many people
- 144 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Mar 2025to 1 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients for inclusion in the study are those with PDPN as assessed by the Douleur Neuropathique 4 Interview (DN4I) assessment.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Patient, who in the opinion of the Investigator, is not likely to complete the study for any reason
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Center for Interventional Pain and Spine
Bryn Mawr, Pennsylvania, 19010
Iqra Research
Cincinnati, Ohio, 45248
Iqra Research
Edgewood, Kentucky, 41017
Center for Interventional Pain and Spine
Fort Washington, Pennsylvania, 19034
Horizon Clinical Research
Gainesville, Georgia, 30501
Horizon Clinical Research
Jasper, Georgia, 30143
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17601
Horizon Clinical Research
Newnan, Georgia, 30265
Curalta Clinical Trials
Oradell, New Jersey, 07649
Center for Interventional Pain and Spine
Wilmington, Delaware, 19808
About this study
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
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.
- Being tested
- Capsaicin 8%
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin 8%Drug
Repeat applications every 12 weeks in patients with PDPN of the feet.
| Study group | Role | What they receive |
|---|---|---|
| Study group | All subjects will receive repeat applications of the capsaicin 8% topical system every 12 weeks (up to 3 applications). Receives: Drug: Capsaicin 8% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: through study completion, an average of 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start14 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Averitas Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495424
- Sponsor's protocol ID
- AV002
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No