Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis

NCT05240872 | Completed Phase 3 DMC

• 1 other identifier: 13.02.2020/008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To explore effects of Autologous Blood Injection versus Platelet Rich plasma injection for treatment of chronic plantar fasciitis

Conditions

Plantar Fascitis

Keywords

heel pain, platelet rich plasm, autologous blood injection

Outcome Measures

Primary Outcomes (3)

• Changes in Visual Analogue Scale (VAS)

  Visual Analogue Scale 10 worst 0-1 best in terms of pain outcome

  0,1 st 3rd and 6th month; changes between time points will be assessed

• Changes in American Orthopaedic Foot & Ankle Society (AOFAS ) Score

  American Orthopaedic Foot \& Ankle Society (AOFAS) Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes Evaluation:0 worst 100 best

  0,1 st 3rd and 6th month; changes between time points will be assessed

• Changes in Foot and Ankle Disability Index (FADI)

  Foot and Ankle Disability Index Evaluation:0 worst 100 best

  0,1 st 3rd and 6th month; changes between time points will be assessed

Study Arms (2)

Group A

ACTIVE COMPARATOR

Platelet Rich Plasm (PRP) injection group

Biological: PRP injection

Group B

ACTIVE COMPARATOR

Autologous Blood injection (ABI) group

Biological: ABI injection

Interventions

PRP injection BIOLOGICAL

Plantar fascia injection therapy with PRP

Group A

ABI injection BIOLOGICAL

ABI injection

Group B

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who were diagnosed with chronic plantar fasciitis
• Nonresponded to o conservative treatment (stretching exercises, nonsteroidal anti-inflammatory drugs, and heel pads) for at least 6 weeks
• Patient should be able to understand the informed consent about type of treatment and blindness and randomization
• Visual analog scale pain higher than 5 (on a 10-point visual analog scale)

You may not qualify if:

• previous history of any type of local injection treatment for heel pain
• history of surgery for heel pain, foot and ankle disorders, fractures
• Associated pathology involving the lower limb such as
• tarsal tunnel syndrome
• effusion of the ankle indicating an intra-articular disease
• Peroneal/Achilles/tibialis tendons pathology
• any obvious deformity of foot and ankle,
• Patients with systemic disorder like diabetes mellitus, ankylosing spondylitis rheumatoid arthritis, hematological disease, or gout
• Pregnancy
• Use of antiocoagulation -

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Atasehir Florence Nightingale Hospital

Ataşehir, Istanbul, 34750, Turkey (Türkiye)

Location

Related Publications (26)

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Study Officials

• Celalettin Bildik, MD

  Istanbul Atasehir Florence Nightingale Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedics and Traumatology Specialist

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: February 15, 2022
• Study Start: March 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: January 15, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After acceptance to publish
• Access Criteria: permission of Institutional Review of Board and Ethical Committee

Locations

TU (1)