drugset / Trial / NCT04409600

Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)

NCT04409600

RandomizedFactorialSingle-blindTreatment

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.

Timeline

Start
2020-11-05
Primary completion
2024-12-06
Completion
2024-12-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin Protein / enzyme biologic

Indications