WithdrawnPhase 2

Botulinum Toxin Injection for Functional Popliteal Artery Entrapment Syndrome

Stopped: Funding withdrawn

United States0Started 2019-10-01

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * To participate in the intervention portion of the study, patients must have a confirmed diagnosis of functional PAES. * Patients must report ongoing leg pain during or after physical activity at the time of intervention. * Patients must have failed prior conservative treatment and have been experiencing exertional leg pain for \> 6 months. * Patients must be between the age of 18 and 50. Exclusion Criteria: Any subject will be excluded from the study if he/she has any of the following: * History of muscle/tendon ruptures to the lower extremities * History of a neurological disease that would affect running or jogging * History of adverse reactions to BTX-A * Concomitant diagnosis of exertional compartment syndrome or other cause for leg pain.

What they're measuring

VAS scores

Timeframe: 12 weeks

Lower extremity functional scale scores

Timeframe: 12 weeks

Trial details

NCT IDNCT03631966

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-31