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NCT03922139 · ClinicalTrials.gov registry record · Phase 1
Botox for the Treatment of Chronic Exertional Compartment Syndrome
A Phase 1 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03922139: Clinical Trial Phase 1 study, sponsored by University of Wisconsin, Madison.
NCT03922139 is a Phase 1 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03922139, a Phase 1 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
After diagnosis of Chronic Exertional Compartment Syndrome (CECS), the participants will be referred to both physical therapy and Botox injection. In physical therapy, the therapist will perform strength measurements of the lower leg (ankle plantarflexion and dorsiflexion) which will be repeated 2 months following the injection. An ultrasound-guided injection of 50 units of Botox will be administered into the tibialis anterior. 25 units will be injected into two different spots in the muscle one being more proximal and the other distal. This will be a one-time injection and will be observed as to how it effects participant symptoms over the next 6 months at either a clinic visit (at 2 months) or telephone call (at 4 and 6 months after injection) via the University of Wisconsin Running Index. Two months following the injection, the participant will undergo repeat measurements of strength using the Kiio Force Sensor. Should potential participants of childbearing potential wish to enroll in the study, a urine pregnancy test will be performed prior to enrollment; participants will not be enrolled if test is positive.
Primary Outcome
Percentage of Relief of Pain will be assessed at each time point (2,4,6 months) using Friedman's ANOVA.
Interventions
- DRUG OnabotulinumtoxinA Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2021-12-15 |
| Phase | Phase 1 |
Why NCT03922139 stopped before completion
NCT03922139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which OnabotulinumtoxinA Injection is the first listed.
NCT03922139 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03922139 about?
NCT03922139 is a clinical study titled "Botox for the Treatment of Chronic Exertional Compartment Syndrome". After diagnosis of Chronic Exertional Compartment Syndrome (CECS), the participants will be referred to both physical therapy and Botox injection. In physical therapy, the therapist will perform strength measurements of the lower leg (ankle plantarflexion and dorsiflexion) which will be repeated 2 m...
What is the current status of trial NCT03922139?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2019-10-08. Estimated completion is 2021-12-15.
What interventions are being tested in trial NCT03922139?
The interventions under investigation include: OnabotulinumtoxinA Injection (DRUG).
Who is sponsoring clinical trial NCT03922139?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03922139's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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