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Botulinum Toxin

Non-Surgical Treatments for Compartment Syndrome

Phase 2
Waitlist Available
Led By Jeffrey Leggit, MD
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets clinical diagnostic criteria for CECS of the anterior or lateral compartment per clinical examination (palpation, intramuscular compartment pressure, lower leg MRI)
Unable to run 2 miles without producing pain and/or symptoms
Must not have
Prior botulinum injection in the lower leg compartment of the affected limb
Prior compartment release of affected lower leg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
Awards & highlights
No Placebo-Only Group

Summary

This trial evaluates non-surgical treatments like gait retraining and botulinum toxin injections for highly active individuals with lower leg pain due to CECS. These treatments aim to reduce pain by changing movement patterns and relaxing muscles. Botulinum toxin injections have been used to treat spasticity in stroke patients and muscle imbalance syndromes in sports medicine.

Who is the study for?
This trial is for active duty service members who can't run 2 miles without leg pain, have trouble with physical training due to lower leg symptoms, and are fluent in English. They must be diagnosed with CECS of the anterior or lateral compartments but haven't had botulinum injections, compartment release surgery, recent limb injuries requiring medical intervention, gait retraining recently, or any allergies to botulinum toxin.
What is being tested?
The study compares non-surgical treatments for CECS: saline injections versus botulinum toxin injections and home-based versus supervised gait retraining. The goal is to see which method best reduces pain during exertion over a follow-up period of at least two years across multiple sites.
What are the potential side effects?
Botulinum toxin may cause muscle weakness, injection site reactions or spread beyond the injection area affecting breathing and swallowing. Saline injections might lead to discomfort at the injection site. Gait retraining generally has minimal side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with CECS in my lower leg based on a physical exam and tests.
Select...
I cannot run 2 miles without feeling pain or other symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a botulinum injection in my affected lower leg.
Select...
I had surgery to relieve pressure in my lower leg.
Select...
I had a leg injury in the last 6 months that required medical care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Balance Error Scoring System Score
Change in Global Rate of Change Score
Change in Patient Specific Functional Scale Scores
+5 more
Secondary study objectives
Ability to perform service specific military physical training requirements
Pain reduction
Patient satisfaction of treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Supervised Gait Retraining + Botulinum Toxin InjectionExperimental Treatment2 Interventions
Group II: Home Based Gait Retraining + Botulinum Toxin InjectionExperimental Treatment2 Interventions
Group III: Supervised Gait Retraining + Saline InjectionActive Control2 Interventions
Group IV: Home Based Gait Retraining + Saline InjectionActive Control2 Interventions

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor
140 Previous Clinical Trials
33,127 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
123 Previous Clinical Trials
90,613 Total Patients Enrolled
Jeffrey Leggit, MDPrincipal InvestigatorUniformed Services University of the Health Sciences

Media Library

Botulinum Toxin Injection (Botulinum Toxin) Clinical Trial Eligibility Overview. Trial Name: NCT04409600 — Phase 2
Chronic Exertional Compartment Syndrome Research Study Groups: Home Based Gait Retraining + Botulinum Toxin Injection, Supervised Gait Retraining + Botulinum Toxin Injection, Supervised Gait Retraining + Saline Injection, Home Based Gait Retraining + Saline Injection
Chronic Exertional Compartment Syndrome Clinical Trial 2023: Botulinum Toxin Injection Highlights & Side Effects. Trial Name: NCT04409600 — Phase 2
Botulinum Toxin Injection (Botulinum Toxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04409600 — Phase 2
~9 spots leftby Nov 2025
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