Botox for Chronic Exertional Compartment Syndrome

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Wisconsin Hospital and Clinics, Madison, WI
Chronic Exertional Compartment Syndrome+3 More
Botox - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether Botox injections into the affected muscle group can reduce pain associated with R-CECS.

See full description

Eligible Conditions

  • Chronic Exertional Compartment Syndrome
  • Compartment Syndrome of Leg

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Botox will improve 3 primary outcomes and 12 secondary outcomes in patients with Chronic Exertional Compartment Syndrome. Measurement will happen over the course of baseline and month 2.

baseline and month 2
Change in ankle dorsiflexion strength using Kiio Force Sensor
Change in ankle eversion strength using Kiio Force Sensor
Change in ankle inversion strength using Kiio Force Sensor
Change in ankle plantarflexion strength using Kiio Force Sensor
Month 6
Change in Pain Score
Change in ability to perform activities of daily living
Change in running duration: longest run
Change in running duration: weekly
Change in running speed
Pain in the 24 hours following running
Participant confidence in increasing the duration and intensity of running
Participant frustration with injury
Participant perception of recovery from injury
up to 6 months
Incidence of Adverse Events
Number of Participants with Lower Extremity Weakness

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Side Effects for

High Volume, High Dose
Increased Salivation
11%
Altered Mental Status
11%
Visual Change
11%
Cough
11%
Bowel urgency
11%
Foot pain
0%
This histogram enumerates side effects from a completed 2010 Phase 4 trial (NCT00178646) in the High Volume, High Dose ARM group. Side effects include: Increased Salivation with 11%, Altered Mental Status with 11%, Visual Change with 11%, Cough with 11%, Bowel urgency with 11%.

Trial Design

1 Treatment Group

Participants with R-CECS
1 of 1
Experimental Treatment

This trial requires 10 total participants across 1 different treatment group

This trial involves a single treatment. Botox is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Participants with R-CECS
Drug
Botox to be injected under standard palpatory technique into the affected lower leg compartment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 2 months, 4 months, 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 2 months, 4 months, 6 months for reporting.

Closest Location

University of Wisconsin Hospital and Clinics - Madison, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Chronic Exertional Compartment Syndrome or one of the other 3 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Documented diagnosis of R-CECS determined with elevated compartmental pressure testing following lower extremity fascia release (fasciotomy or fasciectomy)
Females of childbearing potential must have a negative urine pregnancy test prior to enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.
Willing to provide written informed consent
Willing to comply with all study procedures and be available for the duration of the study
Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Patient Q&A Section

Can compartment syndromes be cured?

"Surgical intervention can be successful in treating compartment syndromes. For this reason, a diagnosis of compartment syndrome should be considered a surgical emergency and it is recommended that a compressive dressing be applied as soon as possible. Early surgical intervention may be recommended in any case of compartment syndrome, due to the higher likelihood of successful management." - Anonymous Online Contributor

Unverified Answer

What causes compartment syndromes?

"There is an emerging body of evidence to strongly suggest that compartment syndrome is a pathophysiological mechanism for the development of compartment syndrome. A number of hypotheses have been presented to account for these findings, including decreased blood flow to areas exposed to increased pressures generated during increased compression. However, the results of animal studies have raised serious doubts as to how the development of compartment syndrome can be explained in this manner. If the evidence of animal models is correct, the mechanisms involved would represent novel mechanisms for why patients with deep venous disease develop compartment syndrome." - Anonymous Online Contributor

Unverified Answer

What are common treatments for compartment syndromes?

"Compartment syndromes can have a long-lasting effect on the patient's mobility. When these problems become evident, an appropriate diagnosis must be obtained early and an appropriate treatment must be prescribed early in the course of the disease." - Anonymous Online Contributor

Unverified Answer

What is compartment syndromes?

"Compartment syndrome is a constellation of symptoms due to ischemia of tissue caused by compression by surrounding edema and is characterized by decreased perfusion (relative hyperemia) in a specific region of the extremity. This occurs in various settings and may range from mild symptoms, to life-threatening symptoms." - Anonymous Online Contributor

Unverified Answer

What are the signs of compartment syndromes?

"The lack of consensus and the small number of reported cases in the literature makes the signs of compartment syndrome difficult to identify. Most cases of compartment syndrome are associated with trauma and therefore are not indicative of compartment syndrome. Most of the signs of compartment syndrome are" - Anonymous Online Contributor

Unverified Answer

How many people get compartment syndromes a year in the United States?

"The number of cases of compartment syndrome that happen at the level of the thigh in the United States is less than 1% of cases per year. The most common cause of this condition is a leg injury. In the United States, compartment syndrome affects 3% of leg injuries." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of compartment syndromes?

"The leading causes of compartment syndromes are venous insufficiency and acute limb ischemia because of a chronic disease. Although both disorders are common, only when combined can predispose a patient to compartment syndrome." - Anonymous Online Contributor

Unverified Answer

Does botox improve quality of life for those with compartment syndromes?

"Although botox injection is well tolerated, there were no significant correlations between botox injection and any HRQOL or symptom severity in participants with CS after 12 weeks." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets compartment syndromes?

"The average age at presentation of patients with compartment syndromes is 56 years old, and the average age of a new patient was 51 years old. The highest percentage of men (82%) in the study were older than 53 years." - Anonymous Online Contributor

Unverified Answer

Is botox typically used in combination with any other treatments?

"Botulinum toxin should be considered whenever appropriate in the treatment of compartment syndrome. The clinical trial database provides a comprehensive list of botulinum toxin product usage in patients with compartment syndrome. We could not determine the usage of bcl toxin in patients with compartment syndromes because of the lack of available evidence." - Anonymous Online Contributor

Unverified Answer

What is the latest research for compartment syndromes?

"It is important to define the definition of compartment syndrome as some definitions omit compartment syndrome as of primary concern. Further research is necessary to elucidate how to define compartment syndrome and how to reduce the risk of compartment syndrome." - Anonymous Online Contributor

Unverified Answer

How serious can compartment syndromes be?

"For many patients, compartment syndromes can be treated safely and effectively via fasciotomy without any permanent impairment of limb function. For some patients, however, the condition is so severe that amputation is the only option in which limb is saved and in which patient functional impairment is minimal." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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