Trial · NCT05254457
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants reporting adverse events (AE) | Day 1 to Day 450 | Proportion of participants reporting AE during the study assessed by incidence, severity and duration |
| Secondary | Change from baseline on the Foot Function Index (FFI) total score in participants treated in the parent studies, and participants retreated in this study | Observational Days 60, 120, 180, 270, 360, and 450 | Change from baseline on the FFI total score on a 5-point rating scale (0-4). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme. |
| Secondary | Change from baseline on the Foot Function Index (FFI) subscales in participants treated in the parent studies, and participants retreated in this study | Observational Days 60, 120, 180, 270, 360, and 450 | Change from baseline on the FFI subscales (pain, difficulty, and activity limitation). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme. |
| Secondary | Change from baseline in the nodular hardness in participants treated in the parent studies, and participants retreated in this study | Observational Days 60, 120, 180, 270, 360, and 450 | Change from baseline in the nodular hardness of the treated nodules measured by durometer |
| Secondary | Change from baseline in the nodular consistency of the treated nodules by palpation in participants treated in the parent studies, and participants retreated in this study | Observational Days 60, 120, 180, 270, 360, and 450 | Change from baseline in the nodular consistency of the treated nodules by palpation |
| Secondary | Change from baseline on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study | Observational Days 60, 120, 180, 270, 360, and 450 | Change from baseline on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable) |
| Secondary | Proportion of participants that meet Treatment Session 1 criteria in the parent studies, and participants retreated in this study | Days 180 or 270 | Proportion of participants that meet Treatment Session 1 criteria |
| Secondary | Proportion of participants on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study | Observational Days 60, 120, 180, 270, 360, and 450 | Proportion of participants reporting "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale |
| Secondary | Proportion of participants on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study | Observational Days 60, 120, 180, 270, 360, and 450 | Proportion of participants reporting "Minimally Improved" (+1), "Much Improved" (+2) or "Very Much Improved" (+3) on the Clinician Global Impression of Change Scale |
| Secondary | Change from baseline (Retreatment) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study | Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237 | Change from baseline (Retreatment Day 1) with EN3835 on the FFI total score on a 5-point rating scale (0-4). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme. |
| Secondary | Change from baseline (Retreatment) on the Foot Function Index (FFI) subscales (pain, difficulty, and activity limitation) in the parent studies, and participants retreated in this study | Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29,43, 57, 117, 197, and 237 | Change from baseline (Retreatment Day 1) with EN3835 on the FFI subscales (pain, difficulty, and activity limitation). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme. |
| Secondary | Change from baseline (Retreatment) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study | Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237 | Change from baseline (Retreatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer |
| Secondary | Change from baseline (Retreatment Day 1) in the nodular consistency of the treated nodules by palpation in the parent studies, and participants retreated in this study | Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237 | Change from baseline (Retreatment Day 1) with EN3835 in the nodular consistency of the treated nodules by palpation |
| Secondary | Change from baseline (Retreatment Day 1) on the Pain Intensity Numerical Rating Scale (NRS) in the parent studies, and participants retreated in this study | Change from baseline (Retreatment Day 1) to Retreatment Days 15, 29, 43, 57, 117, 197, and 237 | Change from baseline (Retreatment Day 1) with EN3835 on the Pain Intensity NRS ranging from 0 (No Pain) to 10 (Worst Pain Imaginable) |
| Secondary | Proportion of participants reporting on the Subject Satisfaction with Treatment Scale in the parent studies, and participants retreated in this study | Retreatment Days 15, 29, 43, 57, 117, 197, and 237 | Proportion of participants reporting to be "Quiet Satisfied" (+1) and "Very Satisfied" (+2) on the Subject Satisfaction with Treatment Scale on Retreatment Days |
| Secondary | Proportion of participants reporting on the Clinician Global Impression of Change Scale in the parent studies, and participants retreated in this study | Retreatment Days 15, 29, 43, 57, 117, 197, and 237 | Proportion of participants reporting "Minimally Improved" (+1), "Much Improved (+2)" or "Very Much Improved (+3) on the Clinician Global Impression of Change Scale on Retreatment Days |
| Secondary | Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) total score in the parent studies, and participants retreated in this study | Change from baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237 | Change from baseline (Treatment Day 1) with EN3835 on the FFI total score on a 5-point rating scale (0-4). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme. |
| Secondary | Change from baseline (Treatment Day 1) on the Foot Function Index (FFI) subscales in the parent studies, and participants retreated in this study | Change from Baseline (Treatment 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237 | Change from baseline (Treatment Day 1) with EN3835 on the FFI subscales (pain, difficulty, and activity limitation). This score is comprised of activity limitation, difficulty, and pain subscales. Each subscale is scored on a 5-point rating scale, ranging from 0 to 4, with 0 being never, no difficulty, or none and 4 being always, a lot of difficulty, and extreme. |
| Secondary | Change from baseline (Treatment Day 1) in the nodular hardness of the treated nodules in the parent studies, and participants retreated in this study | Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237 | Change from baseline (Treatment Day 1) with EN3835 in the nodular hardness of the treated nodules measured by durometer |
| Secondary | Change from baseline (Treatment Day 1) in the nodular consistency of the treated nodules in the parent studies, and participants retreated in this study | Change from baseline (Treatment Day 1) to Treatment Days 15, 29, 43, 57, 117, 197, and 237 | Change from baseline (Treatment Day 1) with EN3835 in the nodular consistency of the treated nodules be palpation |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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