- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03631966
Botulinum Toxin Injection for Functional Popliteal Artery Entrapment Syndrome
Can Botulinum Toxin Injection Relieve Pain and Improve Function in Patients With Functional Popliteal Artery Entrapment Syndrome?
Study Overview
Status
Intervention / Treatment
Detailed Description
Ten (10) patients with suspected functional popliteal artery entrapment syndrome will be recruited for this study. Dr. Michael Fredericson will recruit patients from local sports medicine clinics and sports teams. Equal men and women will be recruited, between the age of 18 and 50 years. This subcategory will reduce the potential of recruiting patients with age-related confounding causes for their symptoms.
After patients have been identified as having clinical features suggestive of PAES, confirmation of the diagnosis will involve the following in accordance with standards of care: 1) Ankle-brachial index testing with provocative maneuvers (maximal passive dorsiflexion and maximal active plantarflexion, treadmill running at a slope), 2) MRI angiography with provocative maneuvers (maximal plantar and dorsiflexion).
All patients will also complete at baseline a visual analog scale (VAS) of their pain, a lower extremity functional scale (LEFS), and lower extremity ultrasound for evaluation of gastrocnemius muscle size.
Currently, treatment of functional PAES involves surgical intervention frequently involving resection of the gastrocnemius muscle. As part of this study, BTX-A will be administered to the gastrocnemius. Patients will be informed about the indications, contraindications, and adverse events associated with BTX-A injections, and they will be informed of current standard of care options, including surgical intervention. Written consent will be obtained.
Dr. Michael Fredericson will carefully inject BTX-A (Dysport-Ipsen Inc.) 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.
The premise of the intervention is that hypertrophy of the gastrocnemius muscle leads to functional entrapment of the popliteal artery at the level of the popliteal fossa with provocation maneuvers or exercise. By temporarily reducing muscle tone and promoting localized atrophy through BTX-A-induced chemodenervation, this entrapment can be relieved.
The primary outcome measures for this study will be VAS scores, LEFS scores, findings of improved blood flow on ABI with provocative maneuvers, and gastrocnemius size on ultrasound.
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).
At 1 month, 3 months and 6 months post-injection, patients will return for clinical examination, visual analog scale (VAS) score, a lower extremity functional scale (LEFS), and lower extremity ultrasound for evaluation of gastrocnemius muscle size.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Redwood City, California, United States, 94063
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BTX-A injection
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS scores
Time Frame: 12 weeks
|
Visual analog scale scores
|
12 weeks
|
Lower extremity functional scale scores
Time Frame: 12 weeks
|
A patient-reported measure of 20 items used to evaluate the functional status in the presence of lower extremity musculoskeletal disorders
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS scores
Time Frame: 4 weeks, 18 weeks, and 6 months
|
Visual analog scale scores
|
4 weeks, 18 weeks, and 6 months
|
Lower extremity functional scale scores
Time Frame: 4 weeks, 18 weeks, and 6 months
|
A patient-reported measure of 20 items used to evaluate the functional status in the presence of lower extremity musculoskeletal disorders
|
4 weeks, 18 weeks, and 6 months
|
blood flow on ankle-brachial indices
Time Frame: 4 weeks, 12 weeks, and 6 months
|
4 weeks, 12 weeks, and 6 months
|
|
gastrocnemius muscle size
Time Frame: 4 weeks, 12 weeks, and 6 months
|
as measured on lower extremity ultrasound
|
4 weeks, 12 weeks, and 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Arterial Occlusive Diseases
- Disease
- Syndrome
- Popliteal Artery Entrapment Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- abobotulinumtoxinA
Other Study ID Numbers
- 40251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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