Functional Popliteal Artery Entrapment SyndromePhase 2NCT03631966
Botulinum Toxin Injection for Functional Popliteal Artery Entrapment Syndrome
A Phase 2 study testing Dysport in people with Functional Popliteal Artery Entrapment Syndrome and Popliteal Artery Entrapment Syndrome, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Functional Popliteal Artery Entrapment Syndrome, Popliteal Artery Entrapment Syndrome
- What is being tested?
- Dysport
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Botulinum Toxin Injection Relieve Pain and Improve Function in Patients With Functional Popliteal Artery Entrapment Syndrome?
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.
Read the 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.
- Being tested
- Dysport
- Medical subject headings
- Popliteal Artery Entrapment Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DysportDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BTX-A injection | Experimental | Not described Receives: Drug: Dysport |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scores
Visual analog scale scores
Measured: 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
Measured: 12 weeks
Secondary outcomes (4)
VAS scores
Visual analog scale scores
Measured: 4 weeks, 18 weeks, and 6 months
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
Measured: 4 weeks, 18 weeks, and 6 months
blood flow on ankle-brachial indices
Measured: 4 weeks, 12 weeks, and 6 months
gastrocnemius muscle size
as measured on lower extremity ultrasound
Measured: 4 weeks, 12 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Oct 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Popliteal Artery Entrapment SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Fredericson, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631966
- Sponsor's protocol ID
- 40251
- Status last verified
- Mar 2021
- First submitted
- 8 Aug 2017
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Botulinum Toxin Injection Relieve Pain and Improve Function in Patients With Functional Popliteal Artery Entrapment Syndrome?
- ClinicalTrials.gov ID
- NCT03631966
- Acronym / sponsor ID
- 40251
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| BTX-A injection | Experimental | Drug: Dysport |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DysportBTX-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. | Drug | BTX-A injection |
Primary outcome
VAS scores
Time frame: 12 weeks
Visual analog scale scores
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
4 secondary outcomes
VAS scores
Time frame: 4 weeks, 18 weeks, and 6 months
Lower extremity functional scale scores
Time frame: 4 weeks, 18 weeks, and 6 months
blood flow on ankle-brachial indices
Time frame: 4 weeks, 12 weeks, and 6 months
gastrocnemius muscle size
Time frame: 4 weeks, 12 weeks, and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Functional Popliteal Artery Entrapment Syndrome
Not yet recruitingObservational study
Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results
Popliteal Artery Entrapment Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dysport in people with Functional Popliteal Artery Entrapment Syndrome and Popliteal Artery Entrapment Syndrome, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS scores (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.