Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

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 any investigational drugs, biologics, or devices within 30 days prior to enrollment

• Currently or have taken in the past medications that affect neuromuscular function, aminoglycosides, muscle relaxants, or other botulinum neurotoxin agents. Currently taking any blood-thinning medications including, but not limited to Plavix, Coumadin, Eliquis, Xarelto

• Women who are pregnant or breast-feeding

• Vulnerable populations

• Not suitable for study participation due to other reasons at the discretion of the investigator