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Botulinum for Chronic Exertional Compartment Syndrome

NCT03339921 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-03-05

Study results available
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Summary

We will investigate the feasibility of a simple outpatient one time injection regimen for the treatment of Chronic Exertional Compartment Syndrome (CECS). We think botulinum toxin injections will be a potentially cost-effective, low-risk alternative to surgery in reducing pain and returning patients to full activity.

Conditions

  • Chronic Exertional Compartment Syndrome

Interventions

DRUG

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

PROCEDURE

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

Sponsors & Collaborators

  • 375th Medical Group, Scott Air Force Base

    lead FED

Principal Investigators

  • Brett Boyce, MD · Principal Investigator

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2020-05-01
Completion
2020-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339921 on ClinicalTrials.gov