Optimizing treatment for chronic exertional compartment syndrome of the lower extremities: the Botox study, a double-blind randomized placebo controlled trial.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524042-99-00

Enrollment

108

Registered

2026-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic exertional compartment syndrome (CECS) of the leg

Brief summary

Primary outcome measure is a patient reported functioning based on Single Assessment Numeric Evaluation (SANE) score in patients receiving BoNT-A injections compared to placebo using multilevel evaluation.

Detailed description

Secondary outcome is the number of prevented surgical interventions in patients with ant-CECS in patients receiving BoNT-A injection compared to placebo.

Interventions

DRUGSodium Chloride 0.9%

DRUGSolution for Injection

DRUGBOTULINUM TOXIN TYPE A

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Primary outcome measure is a patient reported functioning based on Single Assessment Numeric Evaluation (SANE) score in patients receiving BoNT-A injections compared to placebo using multilevel evaluation.	—

Secondary

Measure	Time frame
Secondary outcome is the number of prevented surgical interventions in patients with ant-CECS in patients receiving BoNT-A injection compared to placebo.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 16, 2026