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NCT04409600 · ClinicalTrials.gov registry record · Phase 2
Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
A Phase 2 study, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT04409600: Completed Phase 2 study, sponsored by Walter Reed National Military Medical Center.
NCT04409600 is a Phase 2 study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04409600, a Phase 2 study, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
Chronic Exertional Compartment Syndrome (CECS) in the lower leg is a debilitating condition in highly active individuals. Pain occurs in 1 or several leg compartments upon an exertional activity, typically running, that quickly dissipates once the activity stopped. Surgical fasciotomy is the standard for treating lower leg CECS, but success is variable. Complications may occur post-surgery and there is a potential for a repeat procedure. Recovery times post-surgery also vary greatly. Conservative treatments, such as gait retraining and botulinum toxin injections, are emerging as non-surgical options for the treatment of CECS with success through published case reports and case series. This study aims to evaluate the use of these non-surgical treatment options for CECS in the anterior and lateral leg compartments with a follow up for at least 2 years across multiple study sites.
Primary Outcome
The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability.
Interventions
- DRUG Saline Injection
- BEHAVIORAL Supervised Gait Retraining
- BEHAVIORAL Home Based Gait Retraining
- DRUG Botulinum Toxin Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-11-05 |
| Est. Completion | 2024-12-06 |
| Phase | Phase 2 |
What the finished NCT04409600 record still lists
NCT04409600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 4 interventions - of which Saline Injection is the first listed.
NCT04409600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04409600 about?
NCT04409600 is a clinical study titled "Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)". Chronic Exertional Compartment Syndrome (CECS) in the lower leg is a debilitating condition in highly active individuals. Pain occurs in 1 or several leg compartments upon an exertional activity, typically running, that quickly dissipates once the activity stopped. Surgical fasciotomy is the standar...
What is the current status of trial NCT04409600?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2020-11-05. Estimated completion is 2024-12-06.
What interventions are being tested in trial NCT04409600?
The interventions under investigation include: Saline Injection (DRUG), Supervised Gait Retraining (BEHAVIORAL), Home Based Gait Retraining (BEHAVIORAL), Botulinum Toxin Injection (DRUG).
Who is sponsoring clinical trial NCT04409600?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04409600's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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