Trial Outcomes & Findings for Botulinum for Chronic Exertional Compartment Syndrome (NCT NCT03339921)

Last Updated: 2024-03-05

Results Overview

The Lower Extremity Functional Index measures the functional impairment of a patient with a lower extremity disorder. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. Score ranges from 0 to 80. Lower scores indicate more functional impairment.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

3 participants

Primary outcome timeframe

6 months

Results posted on

2024-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Botulinum Toxin Injections Botulinum toxin injections for chronic compartment syndrome Botulinum toxin injections for chronic compartment syndrome: Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe	Surgical Fasciotomy surgical fasciotomy for chronic compartment syndrome surgical fasciotomy for chronic compartment syndrome: linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment
Overall Study STARTED	3	0
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Botulinum for Chronic Exertional Compartment Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin Injections n=3 Participants Botulinum toxin injections for chronic compartment syndrome Botulinum toxin injections for chronic compartment syndrome: Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe	Surgical Fasciotomy surgical fasciotomy for chronic compartment syndrome surgical fasciotomy for chronic compartment syndrome: linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	3 participants n=99 Participants	—	3 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

Population: No subjects were analyzed by a biostatistician. This study was terminated because it is unworkable. Raw data are reported.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Injections n=3 Participants Botulinum toxin injections for chronic compartment syndrome Botulinum toxin injections for chronic compartment syndrome: Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe	Surgical Fasciotomy surgical fasciotomy for chronic compartment syndrome surgical fasciotomy for chronic compartment syndrome: linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment
Lower Extremity Functional Index Lower Extremity Functional Scale Immediately Post Treatment	57 score on a scale Interval 48.0 to 67.0	—
Lower Extremity Functional Index Lower Extremity Functional Scale Month 1	60 score on a scale Interval 34.0 to 78.0	—
Lower Extremity Functional Index Lower Extremity Functional Scale Month 2	62 score on a scale Interval 52.0 to 67.0	—
Lower Extremity Functional Index Lower Extremity Functional Scale Month 6	55 score on a scale Interval 45.0 to 68.0	—

Adverse Events

Botulinum Toxin Injections

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgical Fasciotomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Crawford

MOMH

Phone: 7026533583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place