Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

NCT ID: NCT05006417

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2022-11-23

Brief 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.

Detailed Description

Participants will be enrolled in study at initial clinic visit by study staff at which time diagnosis of R-CECS will be established based on elevated pressure measurements in patients who have had surgical release of the affected compartments. Pressure testing will be performed outside of the clinical study and will be required to establish the diagnosis of R-CECS.

Initial clinic visit with study staff will consist of baseline measurements of ankle plantarflexion, dorsiflexion, inversion, and eversion strength using Kiio Force Sensor. The clinic visit with study staff will establish time point 0 and will consist of written consent for participation, Botox injection, and baseline University of Wisconsin Running Index (UWRI). Two months following this visit, the participant will have follow up with study staff. Study staff will again measure ankle strength (ankle inversion, eversion, plantarflexion, and dorsiflexion) using the Kiio Force Sensor utilizing the same strength assessment protocol. Study staff will monitor for side effects and administer the UWRI. Telephone follow up assessment of the UWRI will be made by study staff at 4 and 6 months.

Conditions

Compartment Syndrome of Leg

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with R-CECS

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

Group Type: EXPERIMENTAL

Botox

Intervention Type: DRUG

reconstituted at 100 units/mL, dosage will be based upon the affected muscles

Interventions

Botox

reconstituted at 100 units/mL, dosage will be based upon the affected muscles

Intervention Type: DRUG

Other Intervention Names

OnabotulinumtoxinA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Suer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Protocol Version 8/4/2021

Identifier Type: OTHER

Identifier Source: secondary_id

A536120

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/ORTHO&REHAB/REHAB MED

Identifier Type: OTHER

Identifier Source: secondary_id

2020-1375

Identifier Type: -

Identifier Source: org_study_id