Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis (PF:AutovsPRP)

February 14, 2022 updated by: Ozcan Kaya, Istanbul Training and Research Hospital

Is There Any Advantage of PRP Over Autologous Blood Injection in the Treatment of Chronic Plantar Fasciitis? A Prospective Randomized Double Blinded Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After clinical diagnosis of patients with plantar fasciitis. Patients were divided into two groups. Group A (PRP injection group) and Group B (ABI group) were randomized according to web based block group randomization. Patients were evaluated prior to injection in terms of Health related quality of life scores related to foot and ankle diseases (AOFAS and FADI) and VAS. After injection at 1st, 3rd and 6th months HRQoL were compared between groups. Intra group evaluation for HRQoL were performed at f/up visits. Independent t test and repeated measure ANOVA test used for statistical analysis

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Istanbul
      • Ataşehir, Istanbul, Turkey, 34750
        • Ataşehir Florence Nightingale Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. previous history of any type of local injection treatment for heel pain
  2. history of surgery for heel pain, foot and ankle disorders, fractures

  3. 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,
  4. Patients with systemic disorder like diabetes mellitus, ankylosing spondylitis rheumatoid arthritis, hematological disease, or gout
  5. Pregnancy
  6. Use of antiocoagulation -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Platelet Rich Plasm (PRP) injection group
Biological: PRP injection
Plantar fascia injection therapy with PRP
Active Comparator: Group B
Autologous Blood injection (ABI) group
Biological: ABI injection
ABI injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Visual Analogue Scale (VAS)
Time Frame: 0,1 st 3rd and 6th month; changes between time points will be assessed
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
Time Frame: 0,1 st 3rd and 6th month; changes between time points will be assessed
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)
Time Frame: 0,1 st 3rd and 6th month; changes between time points will be assessed
Foot and Ankle Disability Index Evaluation:0 worst 100 best
0,1 st 3rd and 6th month; changes between time points will be assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Training and Research Hospital

Investigators

  • Principal Investigator: Celalettin Bildik, MD, Istanbul Atasehir Florence Nightingale Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

January 15, 2022

Study Registration Dates

First Submitted

February 13, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.02.2020/008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to permission of Institutional Review of Board and Ethical Committee; Participating demographics, outcome measures may be shared

IPD Sharing Time Frame

After acceptance to publish

IPD Sharing Access Criteria

permission of Institutional Review of Board and Ethical Committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plantar Fascitis

Clinical Trials on PRP injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe