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Neurotoxin

Botox for Compartment Syndrome

Phase 4
Waitlist Available
Led By Michael Suer, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 months, 4 months, 6 months
Awards & highlights

Study Summary

This trial will test whether botox injections can relieve pain for people with a chronic condition called recurrent compartment syndrome.

Eligible Conditions
  • Compartment Syndrome of the Leg

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 months, 4 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 months, 4 months, 6 months 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 Pain Score
Incidence of Adverse Events
Number of Participants with Lower Extremity Weakness
Secondary outcome measures
Change in ability to perform activities of daily living
Change in ankle dorsiflexion strength using Kiio Force Sensor
Change in ankle eversion strength using Kiio Force Sensor
+9 more

Side effects data

From 2010 Phase 4 trial • 33 Patients • NCT00178646
8%
Foot pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Volume, High Dose
High Volume, High Dose
Low Volume, Low Dose

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with R-CECSExperimental Treatment1 Intervention
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
Botox
2014
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,377 Total Patients Enrolled
Michael Suer, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
7 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for this experiment available at the moment?

"According to clinicaltrials.gov, the enrollment for this medical trial is still open; it was initially posted on November 1st 2022 and most recently revised on September 12th 2022."

Answered by AI

Has the Food and Drug Administration sanctioned Botox for medical use?

"Botox scored a 3 on our assessment scale as this is an approved Phase 4 trial, evidence of its safety and efficacy."

Answered by AI

How many individuals are participating in this medical study?

"Affirmative. The clinical trial webpage on clinicaltrials.gov shares that this medical study, initially published on November 1st 2022 is still recruiting patients. 10 people are sought from one locale for the research."

Answered by AI

What have been the outcomes of previous research on Botox?

"At present, 61 medical trials are actively examining the effects of Botox with 20 experiments in their terminal stage. Although most studies take place at Farmington Hills, Michigan, overall 759 sites have declared research efforts into this medication."

Answered by AI

What therapeutic benefits is Botox most frequently used for?

"Botox is a common therapy for urinary incontinence, and has also been proven to have positive effects on spinal cord injuries, blepharospasm, and overactive bladder syndrome (OABs)."

Answered by AI

What goals is this research attempting to accomplish?

"The primary goal of this research, to be evaluated over a period up to 6 months, is the Alteration in Pain Score. Secondary goals encompass Change in Ankle Inversion Strength (measured via Kiio Force Sensor), Modification in Ankle Dorsiflexion Strength (again assessed through Kiio Force Sensor) and Variance in Running Duration Per Week (assessed by UWRI 5-point Likert scale). Analyses shall use Wilcoxon Signed Rank Tests or Linear Mixed Effects Models for Repeated Measures as needed to account for intra-subject correlations."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Colorado
Tennessee
Other
How old are they?
< 18
18 - 65
What site did they apply to?
University of Wisconsin Hospital and Clinics
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome
2022. "Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05006417.
~4 spots leftby Apr 2025
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