drugset / Trial / NCT03631966

Botulinum Toxin Injection for Functional Popliteal Artery Entrapment Syndrome

NCT03631966 ↗

Phase 2 Withdrawn Stanford University
NaSingle-groupOpen-labelTreatment

Summary

Failure to adequately diagnose and treat patients with functional popliteal artery entrapment syndrome (PAES) leads to continued pain, loss of function and poor quality of life for many patients nationwide. Currently, the primary treatment for functional PAES involves muscle resection, sometimes involving large segments of muscle, which itself can lead to functional impairment. As such, a less invasive treatment for functional PAES is desirable. The focus of this work is to determine whether Botulinum toxin type A (BTX-A) injections into the gastrocnemius muscle can lessen the mechanical forces placed on the popliteal artery by the involved muscle, thereby improving symptoms caused by impaired distal blood flow.

Timeline

Start
2019-10-01
Primary completion
2019-12-31
Completion
2019-12-31

Outcome

Outcome not reported

Stopped (Business): “Funding withdrawn”

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 400 iu Intramuscular