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

Primary Purpose

Plantar Fascitis

Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
PRP injection
ABI injection
Sponsored by
Istanbul Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring heel pain, platelet rich plasm, autologous blood injection

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Atasehir Florence Nightingale Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

Platelet Rich Plasm (PRP) injection group

Autologous Blood injection (ABI) group

Outcomes

Primary Outcome Measures

Changes in Visual Analogue Scale (VAS)
Visual Analogue Scale 10 worst 0-1 best in terms of pain outcome
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
Changes in Foot and Ankle Disability Index (FADI)
Foot and Ankle Disability Index Evaluation:0 worst 100 best

Secondary Outcome Measures

Full Information

First Posted
February 13, 2022
Last Updated
February 14, 2022
Sponsor
Istanbul Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05240872
Brief Title
Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis
Acronym
PF:AutovsPRP
Official Title
Is There Any Advantage of PRP Over Autologous Blood Injection in the Treatment of Chronic Plantar Fasciitis? A Prospective Randomized Double Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
Keywords
heel pain, platelet rich plasm, autologous blood injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Platelet Rich Plasm (PRP) injection group
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Autologous Blood injection (ABI) group
Intervention Type
Biological
Intervention Name(s)
PRP injection
Intervention Description
Plantar fascia injection therapy with PRP
Intervention Type
Biological
Intervention Name(s)
ABI injection
Intervention Description
ABI injection
Primary Outcome Measure Information:
Title
Changes in Visual Analogue Scale (VAS)
Description
Visual Analogue Scale 10 worst 0-1 best in terms of pain outcome
Time Frame
0,1 st 3rd and 6th month; changes between time points will be assessed
Title
Changes in American Orthopaedic Foot & Ankle Society (AOFAS ) Score
Description
American Orthopaedic Foot & Ankle Society (AOFAS) Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes Evaluation:0 worst 100 best
Time Frame
0,1 st 3rd and 6th month; changes between time points will be assessed
Title
Changes in Foot and Ankle Disability Index (FADI)
Description
Foot and Ankle Disability Index Evaluation:0 worst 100 best
Time Frame
0,1 st 3rd and 6th month; changes between time points will be assessed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celalettin Bildik, MD
Organizational Affiliation
Istanbul Atasehir Florence Nightingale Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atasehir Florence Nightingale Hospital
City
Ataşehir
State/Province
Istanbul
ZIP/Postal Code
34750
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis

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