Plantar FascitisNCT05066919
Operative Versus Non-operative Treatment of Recalcitrant Plantar Fasciitis - A Randomized Study
A study testing Open plantar fasciotomy and Conservative treatment in people with Plantar Fascitis and Surgical Treatment, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to examine whether patients with heel spurs for more than 6 months, who have been treated conservatively, have better effect of surgery than further conservative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fascitis, Surgical Treatment, Non-operative Treatment
- What is being tested?
- Open plantar fasciotomy and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 31 Oct 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Isolated plantar fasciitis through more than 6 months
- Ultrasonic verification of diagnosis (plantar fascia >4 mm)
- Ability to follow the post-operative- and conservative plans
- Able to give informed consent.
Who cannot join
- Previous surgical treatment of plantar fasciitis or surgery around the heel
- Rheumatic disease
- Diabetes
- Dementia
- Neuropathy
- Known alcohol abuse
- Pareses/paralysis of the affected extremity.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hvidovre Hospital, Department of Ortopedic Surgery
Hvidovre, 2300
About this study
The purpose of the study is to examine whether patients with heel spurs for more than 6 months, who have been treated conservatively, have better effect of surgery than further conservative treatment. The study is performed as a randomized trial with the inclusion of 32 patients divided between open plantar fasciectomy and conservative treatment.
The primary endpoint is Self-Reported-Foot-And-Ankle Score (SEFAS-score) after 24 months.
Read more
Secondary endpoints includes: Pain (Visual analogue score) at first step, rest and activity after 3, 6, 12 and 24 months, SEFAS-score after 3, 6 og 12 months, changes in gait after 6 months (measured with gait-analysis). All endpoints are measured at inclusion.
The power calculation is based on the assumption that surgical treatment gives an improvement in SEFAS-score of 10 points (SD 7.9) after 24 months when compared to conservative treatment together with an alpha-value of 5 % and a beta value of 90 %.
- Being tested
- Open plantar fasciotomy, Conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open plantar fasciotomyProcedure or surgery
In the surgical treated group, the plantar fascia is defined percutaneously (medial and lateral margin). An incision is then made just distal to the heel pad medially over the plantar fascia. A resection is performed 1 cm in length with a width corresponding to 50% of the medial band. The skin is sutured with nylon/nonresorbable suture. Postoperatively, the operated foot is elevated for the first 24 hours. Then free mobilization in postoperative shoe (ProCare shoe) is allowed. The dressing is left untouched for 3-5 days, after which it can be changed to a patch. After 14 days the sutures are removed and the patient allowed using regular shoes.
Conservative treatmentOther
In the conservative treatment group, patients are instructed in performing stretching exercises with plantar fascia specific stretching exercises 10 x 10 seconds, 3 times daily and high load strength training are every other day for 3 months. Each high load strength exercise consists of 3 seconds of concentric phase (lifting up with the heel) and 3 seconds of eccentric phase (lowering the heel) with 2 seconds of isometric pause (pause at maximum lifted heel). 12 repetitions max (RM) are performed, defined as the maximum (over) weight the patient can lift 12 times with full range of motion while performing the exercise correctly. 3 x 12 exercises are performed per workout. After 2 weeks, the load is while the number of repetitions is reduced to 10 RM with an increase to 4 repetitions per workout. After 4 weeks the intensity is increased to 8RM with 5 set. Patients are instructed to increase the load throughout the training period.
| Study group | Role | What they receive |
|---|---|---|
| Operative treatment | Experimental | Patients treated with open plantar fasciotomy Receives: Procedure: Open plantar fasciotomy |
| Conservative treatment | Active comparator | Patients treated non-operatively with exercise Receives: Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported-Foot-And-Ankle Score (SEFAS)
The questionnaire contains 12 items with 5 response options. The questionnaire covers different constructs, which are not reported separately in subscales. The most important of these constructs are pain, function, and limitation of function. Each of the 12 multiple-choice questions scores from 0 to 4 where a sum of 0 points represents the most severe disability and 48 represents normal function.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Jan 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Why it stopped: Due to local changes in patient up-take after COVID it is no longer possible to conduct the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Jantzen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066919
- Sponsor's protocol ID
- 78652
- Status last verified
- Mar 2023
- First submitted
- 30 Sep 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Versus Non-operative Treatment of Recalcitrant Plantar Fasciitis - A Randomized Study
- ClinicalTrials.gov ID
- NCT05066919
- Acronym / sponsor ID
- 78652
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to local changes in patient up-take after COVID it is no longer possible to conduct the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 4 Oct 2021 (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.
The purpose of the study is to examine whether patients with heel spurs for more than 6 months, who have been treated conservatively, have better effect of surgery than further conservative treatment. The study is performed as a randomized trial with the inclusion of 32 patients divided between open plantar fasciectomy and conservative treatment.
The primary endpoint is Self-Reported-Foot-And-Ankle Score (SEFAS-score) after 24 months.
Secondary endpoints includes: Pain (Visual analogue score) at first step, rest and activity after 3, 6, 12 and 24 months, SEFAS-score after 3, 6 og 12 months, changes in gait after 6 months (measured with gait-analysis). All endpoints are measured at inclusion.
The power calculation is based on the assumption that surgical treatment gives an improvement in SEFAS-score of 10 points (SD 7.9) after 24 months when compared to conservative treatment together with an alpha-value of 5 % and a beta value of 90 %.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative treatment | Experimental | Procedure: Open plantar fasciotomyPatients treated with open plantar fasciotomy |
| Conservative treatment | Active comparator | Other: Conservative treatmentPatients treated non-operatively with exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years.
- Isolated plantar fasciitis through more than 6 months
- Ultrasonic verification of diagnosis (plantar fascia >4 mm)
- Ability to follow the post-operative- and conservative plans
- Able to give informed consent.
Key exclusion criteria (7 listed)
- Previous surgical treatment of plantar fasciitis or surgery around the heel
- Rheumatic disease
- Diabetes
- Dementia
- Neuropathy
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 |
|---|---|---|
| Open plantar fasciotomyIn the surgical treated group, the plantar fascia is defined percutaneously (medial and lateral margin). An incision is then made just distal to the heel pad medially over the plantar fascia. A resection is performed 1 cm in length with a width corresponding to 50% of the medial band. The skin is sutured with nylon/nonresorbable suture. Postoperatively, the operated foot is elevated for the first 24 hours. Then free mobilization in postoperative shoe (ProCare shoe) is allowed. The dressing is left untouched for 3-5 days, after which it can be changed to a patch. After 14 days the sutures are removed and the patient allowed using regular shoes. | Procedure or surgery | Operative treatment |
| Conservative treatmentIn the conservative treatment group, patients are instructed in performing stretching exercises with plantar fascia specific stretching exercises 10 x 10 seconds, 3 times daily and high load strength training are every other day for 3 months. Each high load strength exercise consists of 3 seconds of concentric phase (lifting up with the heel) and 3 seconds of eccentric phase (lowering the heel) with 2 seconds of isometric pause (pause at maximum lifted heel). 12 repetitions max (RM) are performed, defined as the maximum (over) weight the patient can lift 12 times with full range of motion while performing the exercise correctly. 3 x 12 exercises are performed per workout. After 2 weeks, the load is while the number of repetitions is reduced to 10 RM with an increase to 4 repetitions per workout. After 4 weeks the intensity is increased to 8RM with 5 set. Patients are instructed to increase the load throughout the training period. | Other | Conservative treatment |
Primary outcome
Self-Reported-Foot-And-Ankle Score (SEFAS)
Time frame: 24 Months
The questionnaire contains 12 items with 5 response options. The questionnaire covers different constructs, which are not reported separately in subscales. The most important of these constructs are pain, function, and limitation of function. Each of the 12 multiple-choice questions scores from 0 to 4 where a sum of 0 points represents the most severe disability and 48 represents normal function.
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 2023.
- Individual participant dataSharing planned: No
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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 study testing Open plantar fasciotomy and Conservative treatment in people with Plantar Fascitis and Surgical Treatment, run by Hvidovre University Hospital at 1 site in Denmark.
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 5 inclusion and 7 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 2023. 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 Denmark. 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.
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?
Self-Reported-Foot-And-Ankle Score (SEFAS) (time frame: 24 Months). 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 2023.