Trial Outcomes & Findings for Botulinum for Chronic Exertional Compartment Syndrome (NCT NCT03339921)
NCT ID: 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
| 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
| 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=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
—
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: No subjects were analyzed by a biostatistician. This study was terminated because it is unworkable. Raw data are reported.
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.
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 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
|
—
|
|
Lower Extremity Functional Index
Lower Extremity Functional Scale Immediately Post Treatment
|
57 score on a scale
Interval 48.0 to 67.0
|
—
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place