Plantar FasciitisPhase 4NCT01509274
Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia
A Phase 4 study testing Plasma, Saline and Physiotherapy + heel cap in people with Plantar Fasciitis, run by Kolding Sygehus at 1 site in Denmark.
Trial summary
The purpose of our study is to determine whether one injection with plasma into the origin of the plantar fascia is an effective treatment of plantar fasciitis. 90 patients will be randomized into three groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Plasma, Saline and Physiotherapy + heel cap
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Jun 2012
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 70 of age
- Sore at the insertion of the plantar fascia on calcaneus
- A VAS score of at least 4 at the insertion of the plantar fascia on calcaneus taking the first step in the morning
- Symptoms for 6 to 12 months
- Ability to understand danish and give informed consent
Who cannot join
- Previously operated in the same ankle or foot
- Pain anywhere else in the foot on palpation otherwise than at the insertion of the plantar fascia on calcaneus
- Inflammatory disease
- Diabetes
- Formerly rupture of the Achilles tendon
- Formerly treated with plasma injections
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- Ongoing infection treated with antibiotics
- Treated with steroid during the trial
- Treatment of the plantar fasciitis exceeding conservative treatment
- Use of crutches, walker or similar
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Sygehus Lillebælt - Kolding Sygehus
Kolding, 6000
Bjørn Nedergaard, Cand. Med.
About this study
Official title: Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia - a Prospective, Randomized and Double Blinded Study.
The purpose of our study is to determine whether one injection with plasma into the origin of the plantar fascia is an effective treatment of plantar fasciitis.
90 patients will be randomized into three groups. 30 patients will be treated with one plasma injection, 30 patients will be treated with one injection with saline and 30 patients will do physiotherapy and use heel cups. The two groups who receive injections will do the same physiotherapy and use heel cups, as the conservatively treated group.
Read more
Both groups randomized to receive an injection will have a 10 ml blood sample taken from their cubital vein. The sample is centrifuged for 5 minutes at 5000 rpm. No additives are added. 3 ml of plasma i obtained, and the syringe i blinded. Is the patient randomized to receive an injection with saline, a similar syringe is blinded with 3 ml of saline. The injection into to the origin of the plantar fascia i done 10 minutes after the sample of blood is obtained. The content of the syringe i blinded to both the investigator and the patient.
The injection i performed from the medial aspect of the heel under guidance of ultrasound. No local/systemic analgetic is used. The content of the syringe is spread using peppering technique into the origin of the plantar fascia.
Patients will do questionnaires at inclusion and after 1, 2, 3, 6 and 12 months. The questionaires will be Foot Function Index and SF-36 as well as questions about their use of analgetics, use of heel cups and intensity of their physiotherapy
- Conditions
- Plantar Fasciitis
- Being tested
- Plasma, Saline, Physiotherapy + heel cap
- Keywords
- Plantar fasciitis, Plasma, PRP, Heel pain
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaBiological
3 ml plasma injected once into the plantar fascia
SalineBiological
3 ml of saline injected once into the plantar fascia
Physiotherapy + heel capOther
Physiotherapy three times a day for 8 weeks. Heel caps until symptoms are gone
| Study group | Role | What they receive |
|---|---|---|
| Plasma | Experimental | Not described Receives: Biological: Plasma |
| Saline | Sham comparator | Not described Receives: Biological: Saline |
| Physiotherapy + heel cap | Active comparator | Not described Receives: Other: Physiotherapy + heel cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on a VAS score
Secondary outcomes (1)
Disability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjørn Nedergaard, Kolding Sygehus
- Investigators
- Bjørn Nedergaard, Cand. Med., Principal investigator, Kolding Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509274
- Sponsor's protocol ID
- KS6000
- Status last verified
- Jan 2012
- First submitted
- 10 Jan 2012
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia - a Prospective, Randomized and Double Blinded Study.
- ClinicalTrials.gov ID
- NCT01509274
- Acronym / sponsor ID
- KS6000
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar fasciitis, Plasma, PRP, Heel pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (estimated)
- First posted
- 12 Jan 2012 (estimated)
- 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 our study is to determine whether one injection with plasma into the origin of the plantar fascia is an effective treatment of plantar fasciitis.
90 patients will be randomized into three groups. 30 patients will be treated with one plasma injection, 30 patients will be treated with one injection with saline and 30 patients will do physiotherapy and use heel cups. The two groups who receive injections will do the same physiotherapy and use heel cups, as the conservatively treated group.
Both groups randomized to receive an injection will have a 10 ml blood sample taken from their cubital vein. The sample is centrifuged for 5 minutes at 5000 rpm. No additives are added. 3 ml of plasma i obtained, and the syringe i blinded. Is the patient randomized to receive an injection with saline, a similar syringe is blinded with 3 ml of saline. The injection into to the origin of the plantar fascia i done 10 minutes after the sample of blood is obtained. The content of the syringe i blinded to both the investigator and the patient.
The injection i performed from the medial aspect of the heel under guidance of ultrasound. No local/systemic analgetic is used. The content of the syringe is spread using peppering technique into the origin of the plantar fascia.
Patients will do questionnaires at inclusion and after 1, 2, 3, 6 and 12 months. The questionaires will be Foot Function Index and SF-36 as well as questions about their use of analgetics, use of heel cups and intensity of their physiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plasma | Experimental | Biological: Plasma |
| Saline | Sham comparator | Biological: Saline |
| Physiotherapy + heel cap | Active comparator | Other: Physiotherapy + heel cap |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between 18 and 70 of age
- Sore at the insertion of the plantar fascia on calcaneus
- A VAS score of at least 4 at the insertion of the plantar fascia on calcaneus taking the first step in the morning
- Symptoms for 6 to 12 months
- Ability to understand danish and give informed consent
Key exclusion criteria (11 listed)
- Previously operated in the same ankle or foot
- Pain anywhere else in the foot on palpation otherwise than at the insertion of the plantar fascia on calcaneus
- Inflammatory disease
- Diabetes
- Formerly rupture of the Achilles tendon
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 |
|---|---|---|
| Plasma3 ml plasma injected once into the plantar fascia | Biological | Plasma |
| Saline3 ml of saline injected once into the plantar fascia | Biological | Saline |
| Physiotherapy + heel capPhysiotherapy three times a day for 8 weeks. Heel caps until symptoms are gone | Other | Physiotherapy + heel cap |
Primary outcome
Pain on a VAS score
1 secondary outcome
Disability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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.
Bjørn Nedergaard, Cand. Med. principal investigator
Kolding Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasma, Saline and Physiotherapy + heel cap in people with Plantar Fasciitis, run by Kolding Sygehus 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 11 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: status not confirmed, as of the sponsor's last update on 18 Jan 2012. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bjørn Nedergaard, Cand. Med. (0045 20204541, bspn77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on a VAS score. 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 18 Jan 2012.