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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | All subjects will receive repeat applications of the capsaicin 8% topical system every 12 weeks (up to 3 applications). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin 8% | Drug | Repeat applications every 12 weeks in patients with PDPN of the feet. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The patients for inclusion in the study are those with PDPN as assessed by the Douleur Neuropathique 4 Interview (DN4I) assessment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interventional Pain and Spine | Wilmington | Delaware | 19808 | United States | ||
| Horizon Clinical Research |
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| 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 |
| Iqra Research | Cincinnati | Ohio | 45248 | 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 |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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