Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

Phase 4TerminatedNCT05006417

University of Wisconsin, Madison1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Compartment Syndrome of Leg

Interventions

BotoxDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Change in Pain Score

Change in pain score (0-10, where 10 is increased pain) will be assessed at each time point will be assessed at each time point (2, 4, 6 months) using Friedman's ANOVA.

Time frame: 2 months, 4 months, 6 months

Number of Participants With Lower Extremity Weakness

A primary safety endpoint is incidence of lower extremity weakness, measured by

Time frame: up to 6 months

Incidence of Adverse Events

A primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given.

Time frame: one study visit (within 2 hours)

Secondary Outcomes

Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor

A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).

Time frame: baseline and month 2

Change in Ankle Plantarflexion Strength Using Kiio Force Sensor

Time frame: baseline and month 2

Change in Ankle Inversion Strength Using Kiio Force Sensor

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.