Compartment Syndrome of Leg Clinical Trial
Official title:
OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04113954 -
Detecting Compartment Syndrome Pain in the Presence of Regional Anesthesia in Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT03922139 -
Botox for the Treatment of Chronic Exertional Compartment Syndrome
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT03359031 -
Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption
|
N/A | |
Completed |
NCT04442672 -
Early Diagnosis of Compartment Syndrome by Multimodal Detection Technique
|
N/A | |
Enrolling by invitation |
NCT03604029 -
Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities
|
||
Recruiting |
NCT05830721 -
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
|
N/A | |
Recruiting |
NCT06050499 -
Chemical Analysis of Limb Microfluidics
|
||
Recruiting |
NCT04806555 -
Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation
|
N/A | |
Not yet recruiting |
NCT06079255 -
Ischemia Detection During Development of Acute Compartment Syndrome
|
||
Recruiting |
NCT05466539 -
Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A
|
Phase 4 |