Botulinum for Chronic Exertional Compartment Syndrome

NCT03339921 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: FWH20170037H
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Lower Extremity Functional Index

  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.

  6 months

Study Arms (2)

Botulinum toxin injections

EXPERIMENTAL

Botulinum toxin injections for chronic compartment syndrome

Drug: Botulinum toxin injections for chronic compartment syndrome

surgical fasciotomy

ACTIVE COMPARATOR

surgical fasciotomy for chronic compartment syndrome

Procedure: surgical fasciotomy for chronic compartment syndrome

Interventions

Botulinum toxin injections for chronic compartment syndrome DRUG

Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe

Botulinum toxin injections

surgical fasciotomy for chronic compartment syndrome PROCEDURE

linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment

surgical fasciotomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ages 18-65
• Active duty military
• Unable to run 1.5 miles without producing symptoms, including aching, burning, numbness, tingling, or weakness in the affected limb
• Failed conservative treatment over a period of 2 months, including trial of rest, NSAIDs, icing, and stretching routine
• Meets standard of care clinical diagnostic intramuscular compartment pressure criteria for CECS, based on standardized IMP needle testing. See below for testing protocol and criteria.

You may not qualify if:

• Prior Botulinum toxin injections into the affected limb
• Prior compartment release of the affected limb
• Pregnant or becomes pregnant during the study
• Standard of care clinical exams indicating other more likely causes of leg pain

Sponsors & Collaborators

• 375th Medical Group, Scott Air Force Base: lead

Study Sites (1)

375th Medical Group

Scott Air Force Base, Illinois, 62225, United States

Location

MeSH Terms

Conditions

Chronic Exertional Compartment Syndrome

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated because it is unworkable.

Results Point of Contact

• Title: Amanda Crawford
• Organization: MOMH

amanda.j.rawford.ctr@health.mil

7026533583

Study Officials

• Brett Boyce, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: December 7, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)