Botulinum Toxin Injection for Functional Popliteal Artery Entrapment Syndrome

NCT03631966 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 40251
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Popliteal Artery Entrapment Syndrome; Popliteal Artery Entrapment Syndrome

Outcome Measures

Primary Outcomes (2)

• VAS scores

  Visual analog scale scores

  12 weeks

• Lower extremity functional scale scores

  A patient-reported measure of 20 items used to evaluate the functional status in the presence of lower extremity musculoskeletal disorders

  12 weeks

Secondary Outcomes (4)

• VAS scores

  4 weeks, 18 weeks, and 6 months

• Lower extremity functional scale scores

  4 weeks, 18 weeks, and 6 months

• blood flow on ankle-brachial indices

  4 weeks, 12 weeks, and 6 months

• gastrocnemius muscle size

  4 weeks, 12 weeks, and 6 months

Study Arms (1)

BTX-A injection

EXPERIMENTAL

Drug: Dysport

Interventions

Dysport DRUG

BTX-A (Dysport-Ipsen Inc.) will be injected into the proximal third of the medial and lateral gastrocnemius muscles of the symptomatic leg(s). Total dose per leg will be 400 units, 200 per injection site. Injections will be performed with the aid of real-time ultrasound (Sonosite, Bothwell, WA) guidance.

BTX-A injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Popliteal Artery Entrapment Syndrome

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Stanford PM&R Sports Medicine

Model Details: All patient's recruited to this study will have failed prior conservative treatment, and therefore any improvements seen in symptoms from the BTX-A injection will be considered above and beyond what was provided by conservative care. As such, each patient in this study design acts as their own case control (i.e. there is no appropriate intervention and/or placebo control group for these patients).

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 15, 2018
• Study Start: October 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)