Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

Overseen By Gemma Gliori

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Wisconsin, Madison

Must not be taking: Aminoglycosides, Muscle relaxants, Blood thinners

Disqualifiers: Neuromuscular, Pulmonary, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Trial Summary

What is the purpose of this trial?

This trial tests whether Botox injections can reduce pain in patients with R-CECS who still have pain after surgery. Botox works by stopping the muscles from contracting too much, which helps to lower pain and pressure.

Research Team

Michael Suer, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

Inclusion Criteria

Willing to provide written informed consent

You are 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).

Exclusion Criteria

You have taken medication that affects your muscles or blood clotting in the past, or are currently taking blood-thinning medication.

The investigator has decided that you are not suitable to participate in the study for other reasons.

You have a lung condition such as asthma, pneumonia, or a respiratory infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Clinic Visit

Baseline measurements and Botox injection are administered

1 day

1 visit (in-person)

Treatment Follow-up

Follow-up visit to assess ankle strength and monitor side effects

2 months

1 visit (in-person)

Extended Follow-up

Telephone follow-up assessments of UWRI at 4 and 6 months

4 months

2 visits (virtual)

Treatment Details

Interventions

• Botox

Participant Groups

Group I: Participants with R-CECS Experimental Treatment 1 Intervention

Botox to be injected under standard palpatory technique into the affected lower leg compartment.

Botox is already approved in United States, European Union for the following indications:

Approved in United States as Botox for:

• Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
• Urinary incontinence due to detrusor overactivity associated with a neurologic condition

Approved in European Union as Botox for:

• Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+