Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome (NCT05006417) | Clinical Trial Compass
TerminatedPhase 4
Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome
Stopped: issues with supplier of strength testing equipment, presumed to go out of business
United States1 participantsStarted 2022-11-23
Plain-language summary
10 participants with Recurrent Chronic Exertional Compartment Syndrome (R-CECS) will be enrolled in a 6 month study at the University of Wisconsin Hospitals and Clinics to test the hypothesis that injection of Botox into the affected muscle group will alleviate pain associated with R-CECS.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing to provide written informed consent
* Willing to comply with all study procedures and be available for the duration of the study
* 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.
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* 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).
Exclusion Criteria:
* History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes
* Known neuromuscular disease
* Known pulmonary disease including but not limited to asthma, pneumonia, or upper respiratory tract infection
* Dysphagia
* Known cardiac disease including but not limited to congestive heart failure, arrhythmia, or history of myocardial infarction
* Enrolled in another clinical trial or has used of an…
What they're measuring
1
Change in Pain Score
Timeframe: 2 months, 4 months, 6 months
2
Number of Participants With Lower Extremity Weakness