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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 is a Phase 2 study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 35 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04409600
The ClinicalTrials.gov registry entry for NCT04409600 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Saline Injection is the first listed.
NCT04409600 reports 0 study locations.
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.
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