Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:34 AM
Study NCT ID:
NCT07480967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075527', 'term': 'Prolotherapy'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity measured by the Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 3 months, 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Foot function assessed using the Foot Function Index (FFI)', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 3 months, 6 months', 'description': '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.'}, {'measure': 'Patient satisfaction score by 5-point Likert Scale', 'timeFrame': '2 weeks, 4 weeks, 3 months, 6 months', 'description': '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.'}, {'measure': 'Plantar fascial thickness measured by ultrasound', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 3 months, 6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Planter fasciitis', 'Prolotherapy', 'Platelet Rich Plasma'], 'conditions': ['Planter Fasciitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Dohan Ehrenfest DM,Andia I,Zumstein MA,Zhang CQ,Pinto NR,Bielecki T'}, {'type': 'BACKGROUND', 'citation': 'Capotosto S,Nazemi AK,Komatsu DE,Penna J'}, {'type': 'BACKGROUND', 'citation': 'Ahadi T,Cham MB,Mirmoghtadaei M,Raissi GR,Janbazi L,Zoghi G'}, {'type': 'BACKGROUND', 'citation': 'Michalak N,Banks D,Kane L,Siefferman J'}, {'type': 'BACKGROUND', 'citation': 'Alhakami AM,Babkair RA,Sahely A,Nuhmani S'}, {'pmid': '38264606', 'type': 'BACKGROUND', 'citation': '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': '19019908', 'type': 'BACKGROUND', 'citation': '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': '38021947', 'type': 'BACKGROUND', 'citation': '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': '34941081', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.bmu.ac.bd/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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', 'detailedDescription': '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.\n\nInitial 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.\n\nRegenerative 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.\n\nProlotherapy 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.\n\nDespite 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with plantar fasciitis not responding to conservative therapy.\n\nExclusion Criteria:\n\n* Patients with uncontrolled diabetes, haematological disorders, hepatitis B or C, HIV, clinical signs of acute inflammation, or septicaemia.\n\n * Those receiving local steroid injections within one month.\n * Those receiving non-steroidal anti-inflammatory medications within 72 hours.\n * Platelet levels 25% below the normal level.\n * Patient who had acute ankle or foot trauma, a diagnosis of calcaneal fracture, or stress fracture.'}, 'identificationModule': {'nctId': 'NCT07480967', 'briefTitle': 'Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Bangladesh Medical University'}, 'officialTitle': 'Efficacy Of Platelet Rich Plasma Therapy Versus Prolotherapy In Patients With Plantar Fasciitis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BMU/2026/20/000004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Platelet Rich Plasma (PRP) Therapy', 'description': 'Platelet Rich plasma (PRP) therapy in patients with plantar fasciitis', 'interventionNames': ['Procedure: platelet-rich plasma injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Prolotherapy', 'description': 'Prolotherapy in patients with plantar fasciitis', 'interventionNames': ['Procedure: Prolotherapy with 25% Dextrose']}], 'interventions': [{'name': 'platelet-rich plasma injection', 'type': 'PROCEDURE', 'description': "autologous platelet-rich plasma prepared from the participant's blood and injected into the plantar fascia under aseptic conditions.", 'armGroupLabels': ['Group Platelet Rich Plasma (PRP) Therapy']}, {'name': 'Prolotherapy with 25% Dextrose', 'type': 'PROCEDURE', 'description': 'Injection of hypertonic dextrose solution into the plantar fascia at the site of maximal tenderness to stimulate tissue healing.', 'armGroupLabels': ['Group Prolotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'country': 'Bangladesh', 'contacts': [{'name': 'Kazi Mahzabin Arin, MD', 'role': 'CONTACT', 'email': 'kazimahzabinarin@bsmmu.edu.bd', 'phone': '01754057689'}], 'facility': 'Bangladesh Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Kazi Mahzabin Arin, MD', 'role': 'CONTACT', 'email': 'kazimahzabinarin@bsmmu.edu.bd', 'phone': '+8801754057689'}, {'name': 'AKM Akhtaruzzaman, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'AKM Akhtaruzzaman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bangladesh Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangladesh Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kazi Mahzabin Arin', 'investigatorAffiliation': 'Bangladesh Medical University'}}}}