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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 is a Phase 1 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 7 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03922139
The ClinicalTrials.gov registry entry for NCT03922139 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OnabotulinumtoxinA Injection is the first listed.
NCT03922139 reports 0 study locations.
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.
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