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Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

Primary Purpose

Compartment Syndrome of Leg

Status

Suspended

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Botox

About this trial

This is an interventional treatment trial for Compartment Syndrome of Leg

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with R-CECS

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Pain Score

Change in pain (from baseline on 0-10 numeric rating scale where higher numbers indicate increased pain) will be assessed at each time point (2,4,6 months) using Friedman's ANOVA.

Number of Participants with Lower Extremity Weakness

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

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.

Secondary Outcome Measures

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).

Change in ankle plantarflexion strength using Kiio Force Sensor

Change in ankle inversion strength using Kiio Force Sensor

Change in ankle eversion strength using Kiio Force Sensor

Change in ability to perform activities of daily living

A question on the UWRI asks the participant to indicate how their running injury impacts their ability to perform daily activities. The scoring is on a 5 point likert scale from 0 = unable to perform to 4 = no impact.

Participant frustration with injury

A question on the UWRI asks the participant to indicate how frustrated they are by their running injury. The scoring is on a 5 point likert scale from 0 = extremely frustrated to 4 = not frustrated.

Participant perception of recovery from injury

A question on the UWRI asks the participant to indicate how much recovery have they made from their running injury. The scoring is on a 5 point likert scale from 0 = no recovery to 4 = complete recovery.

Pain in the 24 hours following running

A question on the UWRI asks the participant to indicate how much pain they experience during the 24 hours following a run. The scoring is on a 5 point likert scale from 0 = unable to run to 4 = no pain.

Change in running duration: weekly

A question on the UWRI asks the participant to indicate if their weekly mileage or weekly running time changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run to 4 = same or greater than before my injury.

Change in running duration: longest run

A question on the UWRI asks the participant to indicate if the distance of their longest weekly run has changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run to 4 = same or longer than before my injury.

Change in running speed

Participant confidence in increasing the duration and intensity of running

A question on the UWRI asks the participant to indicate how their injury affects their confidence to increase the duration or intensity of their running. The scoring is on a 5 point likert scale from 0 = I cannot increase my running to 4 = confident to increase my running.

Full Information

NCT ID

NCT05006417

First Posted

August 10, 2021

Last Updated

June 14, 2023

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT05006417

Brief Title

Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

Official Title

OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Suspended

Why Stopped

issues with supplier of strength testing equipment

Study Start Date

November 23, 2022 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Compartment Syndrome of Leg

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Participants with R-CECS

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Botox

Other Intervention Name(s)

OnabotulinumtoxinA

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Pain Score

Description

Change in pain (from baseline on 0-10 numeric rating scale where higher numbers indicate increased pain) will be assessed at each time point (2,4,6 months) using Friedman's ANOVA.

Time Frame

baseline, 2 months, 4 months, 6 months

Title

Number of Participants with Lower Extremity Weakness

Description

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

Time Frame

up to 6 months

Title

Incidence of Adverse Events

Description

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

up to 6 months

Secondary Outcome Measure Information:

Title

Change in ankle dorsiflexion strength using Kiio Force Sensor

Description

Time Frame

baseline and month 2

Title

Change in ankle plantarflexion strength using Kiio Force Sensor

Description

Time Frame

baseline and month 2

Title

Change in ankle inversion strength using Kiio Force Sensor

Description

Time Frame

baseline and month 2

Title

Change in ankle eversion strength using Kiio Force Sensor

Description

Time Frame

baseline and month 2

Title

Change in ability to perform activities of daily living

Description

Time Frame

baseline, 2 months, 4 months, 6 months

Title

Participant frustration with injury

Description

A question on the UWRI asks the participant to indicate how frustrated they are by their running injury. The scoring is on a 5 point likert scale from 0 = extremely frustrated to 4 = not frustrated.

Time Frame

baseline, 2 months, 4 months, 6 months

Title

Participant perception of recovery from injury

Description

Time Frame

baseline, 2 months, 4 months, 6 months

Title

Pain in the 24 hours following running

Description

Time Frame

baseline, 2 months, 4 months, 6 months

Title

Change in running duration: weekly

Description

Time Frame

baseline, 2 months, 4 months, 6 months

Title

Change in running duration: longest run

Description

Time Frame

baseline, 2 months, 4 months, 6 months

Title

Change in running speed

Description

Time Frame

baseline, 2 months, 4 months, 6 months

Title

Participant confidence in increasing the duration and intensity of running

Description

Time Frame

baseline, 2 months, 4 months, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Suer, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin Hospital and Clinics

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

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