Plantar FascitisNCT05589285
Outcomes of Autologous Whole Blood Injection for the Treatment of Plantar Fasciitis
A study testing Injection of autologous whole blood to the plantar fascia and Injection of normal saline to the plantar fascia in people with Plantar Fascitis, run by Sultan Qaboos University at 1 site in Oman.
Trial summary
The aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis. The hypothesis is that Autologous whole blood (AWB) injection is more effective than sham injections in the treatment of plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Injection of autologous whole blood to the plantar fascia and Injection of normal saline to the plantar fascia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteOman
- Study dates
- 13 Jul 2023to 1 Jul 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
- Patients with chronic plantar fasciitis (persistence of symptoms despite 12 weeks of conservative management)
- Age: adults patients more than 18 years
- Not having responded to primary conservative managements such as rest, shoe insoles, conventional physical therapy, exercise therapy, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Who cannot join
- Neurological or vascular insufficiencies in the painful heel
- Osteomyelitis, fracture of the calcaneus
- Recent infection in the treatment area, history of rheumatic diseases
- Immunosuppressive therapy or coagulation disturbance and/or therapy, long-term treatment with corticosteroids
- Previous heel surgery
- Patient with diabetes mellitus,
Show all 10Show fewer
- Pregnancy
- Received corticosteroid injection
- Four weeks since the last anaesthetic injection, iontophoresis, ultrasound and
- electromyostimulation
Trial locations and contacts
1 site in 1 country.
Oman1 site, 1 recruiting
- Recruiting
Sultan Qaboos Univeristy Hospital
Muscat
Wafa Al Baluki, +968 71 9999 31, albaluki@squ.edu.om
About this study
Official title: Outcomes of Autologous Whole Blood Injection for the Treatment of Plantar: A Randomized Controlled Trial.
The aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis.
The hypothesis is that Autologous whole blood (AWB) injection is more effective than sham injections in the treatment of plantar fasciitis.
Participants will receive an autologous whole blood injection over the plantar fascia, and will be followed up to study the response.
Researchers will compare the effects with a control group who will receive normal saline injection.
Read the detailed description
Research objectives and hypothesis. The aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis.
The hypothesis is that AWB injection is more effective than sham injections in the treatment of plantar fasciitis.
Study design and research methods:
- Study design:Randomized prospective single blinded study
- Primary and secondary endpoints: Patients will be followed 6, 12, 24 weeks, and 12 months after the injection to assess the effects and improvement of symptoms. The outcomes will be measured using different scales that reflects resolution of symptoms such us: Visual Analog Scale (VAS), Foot Function Index (FFI) Foot and Ankle Ability Measure (FAAM). All questionnaires will be translated to Arabic for Arabic speakers. Moreover, the thickness of the plantar fascia will be measured by ultrasound before and after treatment. The operator of the ultrasound is a foot and ankle consultant trained on operating ultrasound.
- Study treatments or interventions. Patients with the diagnosis of chronic plantar fasciitis will be recruited to the clinic and asked to participate. The primary investigator and co-investigators will be responsible to explain the nature of the study and take a written informed consent prior to inclusion in the study.
Treatment method for group 1:
Patients assigned in this group will have 2 ml of blood withdrawn from a peripheral vein, then mixed with 1 mL Lidocaine 2% for a total of 3mL volume in one syringe. The patient will be asked to lie down in the clinic bed, and the injection will be administered to the plantar fascia by the principal investigator using a sterile technique.
Treatment method for group 2:
This will be the control group (placebo group). Patients will have 2 ml of blood withdrawn from a peripheral vein for blinding proposes. They will be asked to lie down on the clinic bed, 1 ml of normal saline will be administered under sterile technique by the principal investigator. The blood that was withdrawn initially will be discarded.
Blinding:
Participants will not be aware on the type of injection they received, as both groups will have their blood withdrawn, and the injection will be prepared and given behind a curtain. Blinding of the investigators during treatment administration is not possible as the color of the syringe will give away the type of injection. The type of injection the patient received will not be mentioned in the electronic patient record. Thus, during all the subsequent follow up visits the investigator will not know which treatment group the patient is in to prevent bias.
Post injection:
All patients will be on the conservative management protocol of physiotherapy and orthotics and they will be instructed to perform stretching exercises on daily basis and to record it in dairy. There will be no restrictions in activity. Patients will be instructed not to use NSAIDs.
Randomization:
Patients will be randomized into two groups with a ratio of 1:1 using a computer based randomization system.
- Conditions
- Plantar Fascitis
- Being tested
- Injection of autologous whole blood to the plantar fascia, Injection of normal saline to the plantar fascia
- Keywords
- plantar fasciitis, Whole blood injection
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of autologous whole blood to the plantar fasciaBiological
Patients assigned in this group will have 2 ml of blood withdrawn from a peripheral vein, then mixed with 1 mL Lidocaine 2% for a total of 3mL volume in one syringe. The patient will be asked to lie down in the clinic bed, and the injection will be administered to the plantar fascia by the principal investigator using a sterile technique.
Injection of normal saline to the plantar fasciaDevice
This will be the control group receiving sham injection. Patients will have 2 ml of blood withdrawn from a peripheral vein for blinding proposes. They will be asked to lie down on the clinic bed, 1 ml of normal saline will be administered under sterile technique by the principal investigator. The blood that was withdrawn initially will be discarded.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Chronic plantar fasciitis patients who will receive autologous whole blood injection. Receives: Biological: Injection of autologous whole blood to the plantar fascia |
| Control group | Sham comparator | Chronic plantar fasciitis patients who will receive normal saline injection. Receives: Device: Injection of normal saline to the plantar fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale (VAS) to assess the pain score from 0 (minimum) to 10 (maximum)
Measured: 12 months
Foot Function Index
a questionnaire based index to assess the foot function (from 0% minimum to 100% maximum)
Measured: 12 months
Foot and Ankle Ability Measure (FAAM)
a questionnaire based index to assess foot and ankle ability in various daily life activities.
Measured: 12 months
Change in Plantar fascia thickness
Measurement of the change in plantar fascia thickness using ultrasound
Measured: before the treatment and 12 months after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start13 Jul 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafa Al Baluki, Sultan Qaboos University
- Investigators
- Wafa Al Baluki, Principal investigator, Sultan Qaboos University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589285
- Sponsor's protocol ID
- MREC 2864
- Status last verified
- Jan 2024
- First submitted
- 10 Oct 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Autologous Whole Blood Injection for the Treatment of Plantar: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05589285
- Acronym / sponsor ID
- MREC 2864
- Conditions
- Plantar Fascitis
- Keywords
- plantar fasciitis, Whole blood injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 21 Oct 2022 (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 aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis.
The hypothesis is that Autologous whole blood (AWB) injection is more effective than sham injections in the treatment of plantar fasciitis.
Participants will receive an autologous whole blood injection over the plantar fascia, and will be followed up to study the response.
Researchers will compare the effects with a control group who will receive normal saline injection.
Detailed description
Research objectives and hypothesis. The aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis.
The hypothesis is that AWB injection is more effective than sham injections in the treatment of plantar fasciitis.
Study design and research methods:
- Study design:Randomized prospective single blinded study
- Primary and secondary endpoints: Patients will be followed 6, 12, 24 weeks, and 12 months after the injection to assess the effects and improvement of symptoms. The outcomes will be measured using different scales that reflects resolution of symptoms such us: Visual Analog Scale (VAS), Foot Function Index (FFI) Foot and Ankle Ability Measure (FAAM). All questionnaires will be translated to Arabic for Arabic speakers. Moreover, the thickness of the plantar fascia will be measured by ultrasound before and after treatment. The operator of the ultrasound is a foot and ankle consultant trained on operating ultrasound.
- Study treatments or interventions. Patients with the diagnosis of chronic plantar fasciitis will be recruited to the clinic and asked to participate. The primary investigator and co-investigators will be responsible to explain the nature of the study and take a written informed consent prior to inclusion in the study.
Treatment method for group 1:
Patients assigned in this group will have 2 ml of blood withdrawn from a peripheral vein, then mixed with 1 mL Lidocaine 2% for a total of 3mL volume in one syringe. The patient will be asked to lie down in the clinic bed, and the injection will be administered to the plantar fascia by the principal investigator using a sterile technique.
Treatment method for group 2:
This will be the control group (placebo group). Patients will have 2 ml of blood withdrawn from a peripheral vein for blinding proposes. They will be asked to lie down on the clinic bed, 1 ml of normal saline will be administered under sterile technique by the principal investigator. The blood that was withdrawn initially will be discarded.
Blinding:
Participants will not be aware on the type of injection they received, as both groups will have their blood withdrawn, and the injection will be prepared and given behind a curtain. Blinding of the investigators during treatment administration is not possible as the color of the syringe will give away the type of injection. The type of injection the patient received will not be mentioned in the electronic patient record. Thus, during all the subsequent follow up visits the investigator will not know which treatment group the patient is in to prevent bias.
Post injection:
All patients will be on the conservative management protocol of physiotherapy and orthotics and they will be instructed to perform stretching exercises on daily basis and to record it in dairy. There will be no restrictions in activity. Patients will be instructed not to use NSAIDs.
Randomization:
Patients will be randomized into two groups with a ratio of 1:1 using a computer based randomization system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: Injection of autologous whole blood to the plantar fasciaChronic plantar fasciitis patients who will receive autologous whole blood injection. |
| Control group | Sham comparator | Device: Injection of normal saline to the plantar fasciaChronic plantar fasciitis patients who will receive normal saline injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chronic plantar fasciitis (persistence of symptoms despite 12 weeks of conservative management)
- Age: adults patients more than 18 years
- Not having responded to primary conservative managements such as rest, shoe insoles, conventional physical therapy, exercise therapy, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Key exclusion criteria (10 listed)
- Neurological or vascular insufficiencies in the painful heel
- Osteomyelitis, fracture of the calcaneus
- Recent infection in the treatment area, history of rheumatic diseases
- Immunosuppressive therapy or coagulation disturbance and/or therapy, long-term treatment with corticosteroids
- Previous heel surgery
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 |
|---|---|---|
| Injection of autologous whole blood to the plantar fasciaPatients assigned in this group will have 2 ml of blood withdrawn from a peripheral vein, then mixed with 1 mL Lidocaine 2% for a total of 3mL volume in one syringe. The patient will be asked to lie down in the clinic bed, and the injection will be administered to the plantar fascia by the principal investigator using a sterile technique. | Biological | Treatment group |
| Injection of normal saline to the plantar fasciaThis will be the control group receiving sham injection. Patients will have 2 ml of blood withdrawn from a peripheral vein for blinding proposes. They will be asked to lie down on the clinic bed, 1 ml of normal saline will be administered under sterile technique by the principal investigator. The blood that was withdrawn initially will be discarded. | Device | Control group |
Primary outcome
Visual Analog Scale
Time frame: 12 months
Visual Analog Scale (VAS) to assess the pain score from 0 (minimum) to 10 (maximum)
Foot Function Index
Time frame: 12 months
a questionnaire based index to assess the foot function (from 0% minimum to 100% maximum)
Foot and Ankle Ability Measure (FAAM)
Time frame: 12 months
a questionnaire based index to assess foot and ankle ability in various daily life activities.
Change in Plantar fascia thickness
Time frame: before the treatment and 12 months after the treatment.
Measurement of the change in plantar fascia thickness using ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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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.
Wafa Al Baluki principal investigator
Sultan Qaboos University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of autologous whole blood to the plantar fascia and Injection of normal saline to the plantar fascia in people with Plantar Fascitis, run by Sultan Qaboos University at 1 site in Oman.
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 3 inclusion and 10 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 29 Jan 2024. 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 Oman. 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.
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 Wafa Al Baluki, BSc, MD, FRCSC. (+968 71 9999 31 ext. +968 2414 3486, albaluki@squ.edu.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 12 months). The study lists 4 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 29 Jan 2024.