NCT07480967

Brief 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 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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Apr 2026Feb 2027

First Submitted

Initial submission to the registry

March 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 14, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

Planter fasciitisProlotherapyPlatelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 2 weeks, 4 weeks, 3 months, 6 months

Secondary Outcomes (3)

  • Foot function assessed using the Foot Function Index (FFI)

    Baseline, 2 weeks, 4 weeks, 3 months, 6 months

  • Patient satisfaction score by 5-point Likert Scale

    2 weeks, 4 weeks, 3 months, 6 months

  • Plantar fascial thickness measured by ultrasound

    Baseline, 2 weeks, 4 weeks, 3 months, 6 months

Study Arms (2)

Group Platelet Rich Plasma (PRP) Therapy

ACTIVE COMPARATOR

Platelet Rich plasma (PRP) therapy in patients with plantar fasciitis

Procedure: platelet-rich plasma injection

Group Prolotherapy

ACTIVE COMPARATOR

Prolotherapy in patients with plantar fasciitis

Procedure: Prolotherapy with 25% Dextrose

Interventions

autologous platelet-rich plasma prepared from the participant's blood and injected into the plantar fascia under aseptic conditions.

Group Platelet Rich Plasma (PRP) Therapy

Injection of hypertonic dextrose solution into the plantar fascia at the site of maximal tenderness to stimulate tissue healing.

Group Prolotherapy

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with plantar fasciitis not responding to conservative therapy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (9)

  • Dohan Ehrenfest DM,Andia I,Zumstein MA,Zhang CQ,Pinto NR,Bielecki T

    BACKGROUND
  • Capotosto S,Nazemi AK,Komatsu DE,Penna J

    BACKGROUND
  • Ahadi T,Cham MB,Mirmoghtadaei M,Raissi GR,Janbazi L,Zoghi G

    BACKGROUND
  • Michalak N,Banks D,Kane L,Siefferman J

    BACKGROUND
  • Alhakami AM,Babkair RA,Sahely A,Nuhmani S

    BACKGROUND
  • Tseng 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.

    PMID: 38264606BACKGROUND
  • Ryan 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.

    PMID: 19019908BACKGROUND
  • Pretorius 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.

    PMID: 38021947BACKGROUND
  • Lai 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.

    PMID: 34941081BACKGROUND

Related Links

MeSH Terms

Interventions

ProlotherapyGlucose

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • AKM Akhtaruzzaman, MD

    Bangladesh Medical University

    STUDY DIRECTOR

Central Study Contacts

Kazi Mahzabin Arin, MD

CONTACT

AKM Akhtaruzzaman, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 14, 2026

First Posted

March 18, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations