Platelet Rich Plasma in Plantar Fasciitis

NCT ID: NCT05339542

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2022-07-02

Brief Summary

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a number of patient diagnosed as degenerative plantar fasciitis will be collected and divided into two groups, group I will be injected by platelet rich plasma and group II will be injected methylprednisolone

Detailed Description

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the study will include 100 patients diagnosed as degenerative plantar fasciitis and will be evaluated by musculoskeletal ultrasound by two observes and the will divided randomly into two groups who will be injected under ultrasound imaging by either Platelet rich plasma or methylprednisolone. selection of patient will be randomly and the study will be double blinded.

Conditions

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Plantar Fascitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the study will include two groups. Group I (study group) will be injected PRP. Group II (control group) will be injected methylprednisolone
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Platelet rich plasma group

platelet rich plasma (PRP) will be produced through whole blood centrifuge using a specific methodology in a strict aseptic setting. Then, blood will be collected and mixed with anticoagulant and Citrate-phosphate-dextrose adenine in a 10 volume blood to 1 volume anticoagulant ratio. The blood will be centrifuged for 10 minutes at 1000 rpm. Afterward, the plasma will be transferred to a new glass tube and centrifuged for 15 minutes at 3000 rpm. At the bottom of the tube, platelets will form a pellet. Finally, pure platelet-rich plasma will be obtained at a concentration of up to four times higher than baseline. Prior to the injection, calcium gluconate will be combined with PRP (at a ratio of 0.3 ml ca gluconate/ml PRP).

The injection will be done once.

Group Type EXPERIMENTAL

platelet rich plasma

Intervention Type OTHER

derived from patient own blood

Methylprednisolone group

2 ml methylprednisolone acetate 40mg/ml (total 80mg methylprednisolone acetate) together with 1 ml lidocaine 2% (total 3 ml solution) will be directly injected under ultrasound guidance to the plantar fascia.This group serves as active comparative group.

The injection will be done once.

Group Type ACTIVE_COMPARATOR

MethylPREDNISolone 40 MG

Intervention Type DRUG

active comparative intervention

Interventions

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platelet rich plasma

derived from patient own blood

Intervention Type OTHER

MethylPREDNISolone 40 MG

active comparative intervention

Intervention Type DRUG

Other Intervention Names

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1 ml Lidocaine 2%

Eligibility Criteria

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Inclusion Criteria

\* Clinical diagnosis of plantar fasciitis

Exclusion Criteria

* Rheumatic diseases
* Foot Trauma
* Neurological diseases
* Thyroid disease
* Diabetes mellitus
* Chronic Renal Failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed ElSayed Hafez

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minya university

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Rheumatology Dep.

Identifier Type: -

Identifier Source: org_study_id

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