Planter FasciitisNCT07480967
Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis
A study testing platelet-rich plasma injection and Prolotherapy with 25% Dextrose in people with Planter Fasciitis, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
This randomized controlled trial evaluates the comparative effectiveness of platelet-rich plasma (PRP) therapy and prolotherapy in patients with plantar fasciitis. Both interventions are commonly used regenerative injection therapies intended to improve pain and functional outcomes in patients who do not respond… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Planter Fasciitis
- What is being tested?
- platelet-rich plasma injection and Prolotherapy with 25% Dextrose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Apr 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with plantar fasciitis not responding to conservative therapy.
Who cannot join
- Patients with uncontrolled diabetes, haematological disorders, hepatitis B or C, HIV, clinical signs of acute inflammation, or septicaemia.
- Those receiving local steroid injections within one month.
- Those receiving non-steroidal anti-inflammatory medications within 72 hours.
- Platelet levels 25% below the normal level.
- Patient who had acute ankle or foot trauma, a diagnosis of calcaneal fracture, or stress fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of Platelet Rich Plasma Therapy Versus Prolotherapy In Patients With Plantar Fasciitis: A Randomized Controlled Trial
This randomized controlled trial evaluates the comparative effectiveness of platelet-rich plasma (PRP) therapy and prolotherapy in patients with plantar fasciitis. Both interventions are commonly used regenerative injection therapies intended to improve pain and functional outcomes in patients who do not respond adequately to conventional conservative treatments.
Participants diagnosed with plantar fasciitis will be randomly assigned to receive either PRP injection or prolotherapy. The results of this study aim to identify the more effective injection therapy for improving clinical outcomes in patients with plantar fasciitis
Read the detailed description
Plantar fasciitis is a common musculoskeletal disorder characterized by chronic heel pain resulting from degeneration and microtears of the plantar fascia at its calcaneal insertion. It frequently affects individuals who perform prolonged standing, repetitive walking, or high-impact activities. The condition may lead to persistent discomfort, functional limitation, and reduced quality of life.
Initial management typically includes conservative measures such as rest, stretching exercises, orthotic devices, physiotherapy, and pharmacological pain management. Although many patients respond to these treatments, a subset of patients continues to experience chronic symptoms requiring additional therapeutic options.
Regenerative injection therapies have emerged as alternative treatments for chronic plantar fasciitis. Platelet-rich plasma therapy involves preparing a concentrated platelet suspension from autologous blood and injecting it into the affected region. The platelets release multiple growth factors that may stimulate tissue regeneration, promote collagen synthesis, and enhance healing of the damaged plantar fascia.
Prolotherapy is another injection-based therapy that uses an irritant solution, most commonly hypertonic dextrose, injected at the site of ligament or tendon attachment. The solution induces a controlled inflammatory response that stimulates fibroblast proliferation and connective tissue repair, which may strengthen the affected structures.
Despite the increasing use of PRP therapy and prolotherapy, the comparative effectiveness of these treatments remains uncertain. Evidence comparing the two techniques is limited, and determining their relative benefits may assist clinicians in selecting the most appropriate treatment for patients with persistent plantar fasciitis.
This study is designed as a randomized controlled trial in which eligible participants will be allocated to either PRP therapy or prolotherapy. Clinical outcomes will be assessed during follow-up to determine the effectiveness of each intervention in reducing pain and improving functional status. The findings of this trial may provide evidence to guide treatment decisions for patients with plantar fasciitis who do not respond to conventional conservative management.
- Conditions
- Planter Fasciitis
- Being tested
- platelet-rich plasma injection, Prolotherapy with 25% Dextrose
- Keywords
- Planter fasciitis, Prolotherapy, Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet-rich plasma injectionProcedure or surgery
autologous platelet-rich plasma prepared from the participant's blood and injected into the plantar fascia under aseptic conditions.
Prolotherapy with 25% DextroseProcedure or surgery
Injection of hypertonic dextrose solution into the plantar fascia at the site of maximal tenderness to stimulate tissue healing.
| Study group | Role | What they receive |
|---|---|---|
| Group Platelet Rich Plasma (PRP) Therapy | Active comparator | Platelet Rich plasma (PRP) therapy in patients with plantar fasciitis Receives: Procedure: platelet-rich plasma injection |
| Group Prolotherapy | Active comparator | Prolotherapy in patients with plantar fasciitis Receives: Procedure: Prolotherapy with 25% Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by the Visual Analog Scale (VAS)
Pain intensity will be measured using the Visual Analog Scale (VAS). The Visual Analog Scale is a validated measure of pain intensity consisting of a 10-cm line ranging from 0 to 10, where 0 represents no pain, and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Baseline, 2 weeks, 4 weeks, 3 months, 6 months
Secondary outcomes (3)
Foot function assessed using the Foot Function Index (FFI)
Evaluation of functional limitation and disability related to plantar fasciitis. The total score ranges from 0 to 100, where 0 represents no pain or disability, and 100 represents the worst possible pain and functional limitation. Higher scores indicate worse foot function and greater disability.
Measured: Baseline, 2 weeks, 4 weeks, 3 months, 6 months
Patient satisfaction score by 5-point Likert Scale
Patient satisfaction will be assessed using a 5-point Likert Satisfaction Scale. The scale ranges from 1 to 5, where 1 represents very dissatisfied, 2 represents dissatisfied, 3 represents neutral, 4 represents satisfied, and 5 represents very satisfied. Higher scores indicate greater patient satisfaction with the treatment.
Measured: 2 weeks, 4 weeks, 3 months, 6 months
Plantar fascial thickness measured by ultrasound
Plantar fascial thickness will be measured using diagnostic ultrasound. Plantar fascia thickness will be measured in millimeters (mm) at the point of maximal thickness near the calcaneal insertion using musculoskeletal ultrasound. Increased plantar fascia thickness is associated with greater disease severity, and a reduction in thickness over time indicates improvement.
Measured: Baseline, 2 weeks, 4 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Apr 2026
- Primary completion31 Aug 2026
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Planter 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazi Mahzabin Arin, Bangladesh Medical University
- Investigators
- AKM Akhtaruzzaman, MD, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480967
- Sponsor's protocol ID
- BMU/2026/20/000004
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dohan Ehrenfest DM, Andia I, Zumstein MA, Zhang CQ, Pinto NR, Bielecki T. Classification of platelet concentrates (Platelet-Rich Plasma-PRP, Platelet-Rich Fibrin-PRF) for topical and infiltrative use in orthopedic and sports medicine: current consensus, clinical implications and perspectives. Muscles Ligaments Tendons J. 2014 May 8;4(1):3-9. eCollection 2014 Jan.
PubMed 24932440Capotosto S, Nazemi AK, Komatsu DE, Penna J. Prolotherapy in the Treatment of Sports-Related Tendinopathies: A Systematic Review of Randomized Controlled Trials. Orthop J Sports Med. 2024 Nov 4;12(11):23259671241275087. doi: 10.1177/23259671241275087. eCollection 2024 Nov.
PubMed 39502373Ahadi T, Cham MB, Mirmoghtadaei M, Raissi GR, Janbazi L, Zoghi G. The effect of dextrose prolotherapy versus placebo/other non-surgical treatments on pain in chronic plantar fasciitis: a systematic review and meta-analysis of clinical trials. J Foot Ankle Res. 2023 Feb 10;16(1):5. doi: 10.1186/s13047-023-00605-3.
PubMed 36759882Michalak N, Banks D, Kane L, Siefferman J. Dextrose Prolotherapy for the Treatment of Chronic Shoulder Pain in Patients With Joint Hypermobility: A Case Series. Clin Med Insights Arthritis Musculoskelet Disord. 2024 Jul 24;17:11795441241264821. doi: 10.1177/11795441241264821. eCollection 2024.
PubMed 39055287Alhakami AM, Babkair RA, Sahely A, Nuhmani S. Effectiveness of therapeutic ultrasound on reducing pain intensity and functional disability in patients with plantar fasciitis: a systematic review of randomised controlled trials. PeerJ. 2024 Mar 22;12:e17147. doi: 10.7717/peerj.17147. eCollection 2024.
PubMed 38529309Tseng WC, Chen YC, Lee TM, Chen WS. Plantar Fasciitis: An Updated Review. J Med Ultrasound. 2023 Oct 6;31(4):268-274. doi: 10.4103/jmu.jmu_2_23. eCollection 2023 Oct-Dec.
PubMed 38264606Ryan MB, Wong AD, Gillies JH, Wong J, Taunton JE. Sonographically guided intratendinous injections of hyperosmolar dextrose/lidocaine: a pilot study for the treatment of chronic plantar fasciitis. Br J Sports Med. 2009 Apr;43(4):303-6. doi: 10.1136/bjsm.2008.050021. Epub 2008 Nov 19.
PubMed 19019908Pretorius J, Habash M, Ghobrial B, Alnajjar R, Ellanti P. Current Status and Advancements in Platelet-Rich Plasma Therapy. Cureus. 2023 Oct 17;15(10):e47176. doi: 10.7759/cureus.47176. eCollection 2023 Oct.
PubMed 38021947Lai WF, Yoon CH, Chiang MT, Hong YH, Chen HC, Song W, Chin YPH. The effectiveness of dextrose prolotherapy in plantar fasciitis: A systemic review and meta-analysis. Medicine (Baltimore). 2021 Dec 23;100(51):e28216. doi: 10.1097/MD.0000000000028216.
PubMed 34941081
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Platelet Rich Plasma Therapy Versus Prolotherapy In Patients With Plantar Fasciitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07480967
- Acronym / sponsor ID
- BMU/2026/20/000004
- Conditions
- Planter Fasciitis
- Keywords
- Planter fasciitis, Prolotherapy, Platelet Rich Plasma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Mar 2026 (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.
This randomized controlled trial evaluates the comparative effectiveness of platelet-rich plasma (PRP) therapy and prolotherapy in patients with plantar fasciitis. Both interventions are commonly used regenerative injection therapies intended to improve pain and functional outcomes in patients who do not respond adequately to conventional conservative treatments.
Participants diagnosed with plantar fasciitis will be randomly assigned to receive either PRP injection or prolotherapy. The results of this study aim to identify the more effective injection therapy for improving clinical outcomes in patients with plantar fasciitis
Detailed description
Plantar fasciitis is a common musculoskeletal disorder characterized by chronic heel pain resulting from degeneration and microtears of the plantar fascia at its calcaneal insertion. It frequently affects individuals who perform prolonged standing, repetitive walking, or high-impact activities. The condition may lead to persistent discomfort, functional limitation, and reduced quality of life.
Initial management typically includes conservative measures such as rest, stretching exercises, orthotic devices, physiotherapy, and pharmacological pain management. Although many patients respond to these treatments, a subset of patients continues to experience chronic symptoms requiring additional therapeutic options.
Regenerative injection therapies have emerged as alternative treatments for chronic plantar fasciitis. Platelet-rich plasma therapy involves preparing a concentrated platelet suspension from autologous blood and injecting it into the affected region. The platelets release multiple growth factors that may stimulate tissue regeneration, promote collagen synthesis, and enhance healing of the damaged plantar fascia.
Prolotherapy is another injection-based therapy that uses an irritant solution, most commonly hypertonic dextrose, injected at the site of ligament or tendon attachment. The solution induces a controlled inflammatory response that stimulates fibroblast proliferation and connective tissue repair, which may strengthen the affected structures.
Despite the increasing use of PRP therapy and prolotherapy, the comparative effectiveness of these treatments remains uncertain. Evidence comparing the two techniques is limited, and determining their relative benefits may assist clinicians in selecting the most appropriate treatment for patients with persistent plantar fasciitis.
This study is designed as a randomized controlled trial in which eligible participants will be allocated to either PRP therapy or prolotherapy. Clinical outcomes will be assessed during follow-up to determine the effectiveness of each intervention in reducing pain and improving functional status. The findings of this trial may provide evidence to guide treatment decisions for patients with plantar fasciitis who do not respond to conventional conservative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Platelet Rich Plasma (PRP) Therapy | Active comparator | Procedure: platelet-rich plasma injectionPlatelet Rich plasma (PRP) therapy in patients with plantar fasciitis |
| Group Prolotherapy | Active comparator | Procedure: Prolotherapy with 25% DextroseProlotherapy in patients with plantar fasciitis |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient with plantar fasciitis not responding to conservative therapy.
Key exclusion criteria (5 listed)
- Patients with uncontrolled diabetes, haematological disorders, hepatitis B or C, HIV, clinical signs of acute inflammation, or septicaemia.
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 |
|---|---|---|
| platelet-rich plasma injectionautologous platelet-rich plasma prepared from the participant's blood and injected into the plantar fascia under aseptic conditions. | Procedure or surgery | Group Platelet Rich Plasma (PRP) Therapy |
| Prolotherapy with 25% DextroseInjection of hypertonic dextrose solution into the plantar fascia at the site of maximal tenderness to stimulate tissue healing. | Procedure or surgery | Group Prolotherapy |
Primary outcome
Pain intensity measured by the Visual Analog Scale (VAS)
Time frame: Baseline, 2 weeks, 4 weeks, 3 months, 6 months
Pain intensity will be measured using the Visual Analog Scale (VAS). The Visual Analog Scale is a validated measure of pain intensity consisting of a 10-cm line ranging from 0 to 10, where 0 represents no pain, and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity.
3 secondary outcomes
Foot function assessed using the Foot Function Index (FFI)
Time frame: Baseline, 2 weeks, 4 weeks, 3 months, 6 months
Patient satisfaction score by 5-point Likert Scale
Time frame: 2 weeks, 4 weeks, 3 months, 6 months
Plantar fascial thickness measured by ultrasound
Time frame: Baseline, 2 weeks, 4 weeks, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 24932440Dohan Ehrenfest DM, Andia I, Zumstein MA, Zhang CQ, Pinto NR, Bielecki T. Classification of platelet concentrates (Platelet-Rich Plasma-PRP, Platelet-Rich Fibrin-PRF) for topical and infiltrative use in orthopedic and sports medicine: current consensus, clinical implications and perspectives. Muscles Ligaments Tendons J. 2014 May 8;4(1):3-9. eCollection 2014 Jan.
- Background: PubMed 39502373Capotosto S, Nazemi AK, Komatsu DE, Penna J. Prolotherapy in the Treatment of Sports-Related Tendinopathies: A Systematic Review of Randomized Controlled Trials. Orthop J Sports Med. 2024 Nov 4;12(11):23259671241275087. doi: 10.1177/23259671241275087. eCollection 2024 Nov.
- Background: PubMed 36759882Ahadi T, Cham MB, Mirmoghtadaei M, Raissi GR, Janbazi L, Zoghi G. The effect of dextrose prolotherapy versus placebo/other non-surgical treatments on pain in chronic plantar fasciitis: a systematic review and meta-analysis of clinical trials. J Foot Ankle Res. 2023 Feb 10;16(1):5. doi: 10.1186/s13047-023-00605-3.
- Background: PubMed 39055287Michalak N, Banks D, Kane L, Siefferman J. Dextrose Prolotherapy for the Treatment of Chronic Shoulder Pain in Patients With Joint Hypermobility: A Case Series. Clin Med Insights Arthritis Musculoskelet Disord. 2024 Jul 24;17:11795441241264821. doi: 10.1177/11795441241264821. eCollection 2024.
- Background: PubMed 38529309Alhakami AM, Babkair RA, Sahely A, Nuhmani S. Effectiveness of therapeutic ultrasound on reducing pain intensity and functional disability in patients with plantar fasciitis: a systematic review of randomised controlled trials. PeerJ. 2024 Mar 22;12:e17147. doi: 10.7717/peerj.17147. eCollection 2024.
- Background: PubMed 38264606Tseng WC, Chen YC, Lee TM, Chen WS. Plantar Fasciitis: An Updated Review. J Med Ultrasound. 2023 Oct 6;31(4):268-274. doi: 10.4103/jmu.jmu_2_23. eCollection 2023 Oct-Dec.
- Background: PubMed 19019908Ryan MB, Wong AD, Gillies JH, Wong J, Taunton JE. Sonographically guided intratendinous injections of hyperosmolar dextrose/lidocaine: a pilot study for the treatment of chronic plantar fasciitis. Br J Sports Med. 2009 Apr;43(4):303-6. doi: 10.1136/bjsm.2008.050021. Epub 2008 Nov 19.
- Background: PubMed 38021947Pretorius J, Habash M, Ghobrial B, Alnajjar R, Ellanti P. Current Status and Advancements in Platelet-Rich Plasma Therapy. Cureus. 2023 Oct 17;15(10):e47176. doi: 10.7759/cureus.47176. eCollection 2023 Oct.
- Background: PubMed 34941081Lai WF, Yoon CH, Chiang MT, Hong YH, Chen HC, Song W, Chin YPH. The effectiveness of dextrose prolotherapy in plantar fasciitis: A systemic review and meta-analysis. Medicine (Baltimore). 2021 Dec 23;100(51):e28216. doi: 10.1097/MD.0000000000028216.
- Related InfoLink provided by the sponsor.
- 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.
AKM Akhtaruzzaman, MD study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet-rich plasma injection and Prolotherapy with 25% Dextrose in people with Planter Fasciitis, run by Bangladesh Medical University at 1 site in Bangladesh.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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 Bangladesh. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain intensity measured by the Visual Analog Scale (VAS) (time frame: Baseline, 2 weeks, 4 weeks, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07480967, which also lists 9 linked publications.
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 30 Sep 2026.