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Botulinum Toxin

Non-Surgical Treatments for Compartment Syndrome

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
Awards & highlights

Study Summary

This trial is evaluating the use of conservative treatments, such as gait retraining and botulinum toxin injections, for Chronic Exertional Compartment Syndrome (CECS) of the lower leg.

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.Check my eligibility
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.See study design
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
Select...
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Balance Error Scoring System Score
Change in Global Rate of Change Score
Change in Patient Specific Functional Scale Scores
+5 more
Secondary outcome measures
Ability to perform service specific military physical training requirements
Pain reduction
Patient satisfaction of 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
137 Previous Clinical Trials
33,877 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
90,993 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How do patients qualify to participate in this research?

"The aim is to recruit 620 people aged 18-50 that have chronic exertional compartment syndrome. The most important criteria that patients must meet are as follows: They experience pain and/or symptoms in their lower leg which make it difficult to complete the running portion of their service-specific physical training, They are unable to run 2 miles without producing pain and/or symptoms, They are active duty service."

Answered by AI

Are researchers still looking for participants in this trial?

"This is an active clinical trial that was first posted on November 5th, 2020 according to the website clinicaltrials.gov. The most recent update to the study occurred on May 26th, 2022."

Answered by AI

How many individuals have signed up to participate in this research project?

"According to the latest information available on clinicaltrials.gov, this trial is still recruiting patients. The listing was first posted on November 5th 2020 and has been updated as recently as May 26th 2022. A total of 620 patients are needed at 2 different sites."

Answered by AI

Is this study available to people who are octogenarians?

"This trial is for patients aged 18-50. There are other options available for minors and seniors, with 389 trials catering to those under 18 and 1038 trials specifically for patients over 65 years old."

Answered by AI

Is there a potential for harm when patients receive Botulinum Toxin Injection?

"While there is some data supporting the safety of Botulinum Toxin Injection, it received a score of 2 because there is no evidence that this intervention is effective."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Florida
Other
Kentucky
How old are they?
18 - 65
What site did they apply to?
Fort Belvoir Community Hospital
Walter Reed National Military Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
2020. "Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04409600.
~140 spots leftby Apr 2025
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