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Trial registered on ANZCTR


Registration number
ACTRN12619001765112
Ethics application status
Approved
Date submitted
20/11/2019
Date registered
12/12/2019
Date last updated
12/12/2019
Date data sharing statement initially provided
12/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Microembolisation for plantar heel pain
Scientific title
Evaluating transcatheter arterial embolisation and an anti-inflammatory for improvement of foot pain in people with plantar fasciopathy – a pilot study
Secondary ID [1] 299863 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EIEIOF2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar heel pain 315273 0
Condition category
Condition code
Musculoskeletal 313571 313571 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Embolisation plus NSAID group

Participants in the embolisation plus NSAID group will receive light sedation with midazolam and fentanyl as required and a local anaesthetic injected into their groin. Typical doses of
fentanyl and midazolam are 50mcg and 2mg respectively; both medications are administered intravenously. Femoral artery access will be obtained with a 3 French sheath and a micro-catheter introduced. An angiogram will identify abnormal foot neovasculature which usually appears as a blush-like enhancement. Immediately prior to embolisation, participants will receive an intra-arterial infusion of Ibuprofen (400mg in 4mL) mixed with 6mL contrast via the micro-catheter. The abnormal vessels will be embolised with a suspension of 0.5 g imipenem and cilastatin sodium (Primaxin; Merck & Co, Whitehouse Station, New Jersey, USA) in 5mL of iodinated contrast agent (prepared by pumping syringes for 10s) by injecting 0.2mL increments until blood flow stagnates.

The guide wire will be removed. A dressing will be applied to the puncture site.

All procedures will be conducted by a fully qualified interventional radiologist who is trained to perform vascular embolisation.

The procedure is expected to take 30-60minutes depending on the number of vessels embolised.
Intervention code [1] 316129 0
Treatment: Drugs
Comparator / control treatment
Embolisation only group

Participants in the embolisation only group will receive light sedation with midazolam and fentanyl as required and a local anaesthetic injected into their groin. Femoral artery access will be obtained with a 3 French sheath and a micro-catheter introduced. An angiogram will identify abnormal foot neovasculature. The abnormal vessels will be embolised with a suspension of 0.5 g imipenem and cilastatin sodium (Primaxin; Merck & Co, Whitehouse Station, New Jersey, USA) in 5mL of iodinated contrast agent (prepared by pumping syringes for 10s) by injecting 0.2mL increments until blood flow stagnates.

The guide wire will be removed. A dressing will be applied to the puncture site.

All procedures will be conducted by a fully qualified interventional radiologist who is trained to perform vascular embolisation.

The procedure is expected to take 30-60minutes depending on the number of vessels embolised.
Control group
Active

Outcomes
Primary outcome [1] 322027 0
Change in foot pain as assessed by the Foot and Ankle Outcome Score (FAOS).
Timepoint [1] 322027 0
6 months post intervention
Secondary outcome [1] 377049 0
Change in foot pain as assessed by the Foot and Ankle Outcome Score (FAOS)
Timepoint [1] 377049 0
One and 12 months post intervention
Secondary outcome [2] 377050 0
Change in self-reported physical function as assessed by the Foot and Ankle Outcome Score (FAOS)
Timepoint [2] 377050 0
One, six and 12 months post intervention
Secondary outcome [3] 377051 0
Change in quality of life as assessed by the Foot and Ankle Outcome Score (FAOS)
Timepoint [3] 377051 0
One, six and 12 months post intervention
Secondary outcome [4] 377052 0
Self-reported global assessment of change (7 point scale)
Timepoint [4] 377052 0
One, six and 12 months post intervention

Eligibility
Key inclusion criteria
1. 18 to 85 years of age
2. Moderate to severe plantar heel pain
3. Pain resistant to conservative treatment for at least 3 months
a. at least one conventional therapy such as analgesia, NSAID, corticosteroid injection, orthotics, physiotherapy (e.g. stretching and/or strengthening exercises)
4. Willing, able and mentally competent to provide informed consent
a. able to read and understand the Patient Information and Consent Form which is written in English language
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Local infection
2. Active malignancy
3. Prior ipsilateral foot or ankle surgery
4. Ipsilateral injection into the foot or ankle in the last 3 months
5. Pregnant or trying to become pregnant during the study period
6. History of allergy to contrast media
7. History of allergy to carbapenem (eg, imipenem, ertapenem or meropenem), or having an immediate or severe hypersensitivity reaction to a penicillin or cephalosporin antibiotic;
8. History of seizures or using valproate
9. History of allergy to NSAIDs
10. Reduced kidney function or failure (chronic or acute)
a. Estimated GFR < 30ml/min.1.73m2
b. People on dialysis
11. Body weight greater than 200kg
12. Platelets < 100 x 109/L
13. INR > 1.5
14. Moderate to severe pain in other lower limb joints
15. Previous amputation of ipsilateral toe/s or other part of foot
16. Current or previous ipsilateral foot ulcer
17. Peripheral neuropathy lower limb/s
18. Charcot neuroarthropathy
19. Peripheral vascular disease
20. Rheumatoid arthritis or seronegative arthropathies
21. Ipsilateral foot or ankle pain (excluding plantar heel pain) due to conditions such as achilles tendinopathy or Hallux Abduco Valgus
22. Severe hepatic impairment or heart failure
23. Active or a history of gastrointestinal inflammatory disorder or ulceration, haemorrhage, chronic dyspepsia.
24. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
25. Asthma with known sensitivity to NSAIDs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group assignment will be computer generated and informed using REDCap (Research Electronic Data Capture) online software. The interventionalist will access each participant's group allocation immediately prior to each intervention by logging into REDCap and running the allocation process. Only the interventionalist will be aware of the participant's allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation schedule will be generated by a statistician prior to trial commencement via random block allocation. The allocation schedule will be developed and disseminated via REDCap (Research Electronic Data Capture) online software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis will be performed on an intention-to-treat basis including all randomised participants.

The primary analysis will be performed on the FAOS pain scale, using percentage reduction from baseline and a two-sample t-test if no dropout occurs and all 6 month data is available on each participant. Normality of the outcomes will be assessed, and if the assumptions are not met, the primary analysis will be conducted using the Wilcoxon rank sum test.

In the case of dropouts or missing data at 6 months, the primary analysis will be conducted under a linear regression model, with random effects accounting for intra-individual correlations.

Secondary outcomes:
Outcome data that is available at multiple time points will be analysed using linear regression model, with random effects accounting for intra-individual correlations. Differences between groups will be analysed and presented for each time point using a time-by-intervention product term.

Sample size determinations
Given the exploratory nature of this pilot study, sample sizes were determined pragmatically based on our expected ability to recruit participants within 12months.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15272 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 28581 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 304324 0
Hospital
Name [1] 304324 0
Barwon Health
Address [1] 304324 0
University Hospital Geelong
Bellerine Street
Geelong, Vic, Australia
3220
Country [1] 304324 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
University Hospital Geelong
Bellerine Street
Geelong, Vic, Australia
3220
Country
Australia
Secondary sponsor category [1] 304570 0
None
Name [1] 304570 0
Address [1] 304570 0
Country [1] 304570 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304773 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 304773 0
University Hospital Geelong
Bellerine Street
Geelong, Vic, Australia
3220
Ethics committee country [1] 304773 0
Australia
Date submitted for ethics approval [1] 304773 0
28/08/2019
Approval date [1] 304773 0
20/11/2019
Ethics approval number [1] 304773 0
19/128

Summary
Brief summary
Plantar heel pain, which is often called Plantar Fasciitis, is a common cause of pain and disability. The condition appears to include the proliferation of blood vessels and nerves in the foot which contribute to the experience of pain.

The primary aim of the current study is to determine whether transcatheter arterial embolisation of abnormal neovasculature about the foot improves pain, and specifically if adding an anti-inflammatory medication prior to embolisation affects pain differently than embolisation alone. Secondary aims include whether the treatments affect physical function and quality of life.

The study is a randomised trial. People are eligible if they have plantar foot pain that has not responded to other forms of traditional management such as medications, podiatry or physiotherapy.

Participants will be randomly allocated to one of two groups. Participants in one group will receive embolisation of abnormal vessels about the foot. Participants in the second group group will receive embolisation and an anti-inflammatory medication that is injected in the blood vessels in the foot.

All participants will be assessed shortly before the intervention and then 1, 6 and 12 months after the intervention. Assessment includes a variety of questionnaires and physical tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98158 0
Dr Steve Landers
Address 98158 0
University Hospital Geelong
Bellerine Street
Geelong, Vic, Australia
3220
Country 98158 0
Australia
Phone 98158 0
+61 3 42150000
Fax 98158 0
Email 98158 0
stevel@barwonhealth.org.au
Contact person for public queries
Name 98159 0
Ms Rachael Hely
Address 98159 0
University Hospital Geelong
Bellerine Street
Geelong, Vic, Australia
3220
Country 98159 0
Australia
Phone 98159 0
+61 3 42150000
Fax 98159 0
Email 98159 0
racheahe@barwonhealth.org.au
Contact person for scientific queries
Name 98160 0
Dr Stephen Gill
Address 98160 0
University Hospital Geelong
Bellerine Street
Geelong, Vic, Australia
3220
Country 98160 0
Australia
Phone 98160 0
+61 3 42150000
Fax 98160 0
Email 98160 0
stephen.gill2@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are yet to confirm our data sharing plans.
What supporting documents are/will be available?
No other documents available
Summary results
No Results