<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230111057111N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-04-20</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of two types of PRP injections in patients with plantar fasciitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of PRP Injection Using Peppering and Single-Point Methods in Patients with Plantar Fasciitis: a randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/89499</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Patients will be divided into two groups using a simple randomization method:
- Group A: PRP injection with the peppering technique (3 small injections at points around the plantar fascia).
- Group B: PRP injection with the single-point technique (one concentrated injection at the site of maximum pain and sensitivity), Blinding description: This study is designed as a single-blind study. Patients will not be aware of the type of injection technique (peppering or single-point). The injecting physician will inevitably be aware of the technique, but the clinical assessor (who will record VAS and FFI at subsequent visits) will be completely unaware of the group allocation of patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Plantar fasciitis/heel spur.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A:20 ml of blood is taken from the patient and PRP is prepared with a platelet concentration 4-6 times the baseline using a single-stage centrifuge and the standard Alpha kit. After obtaining informed consent, PRP is injected by palpation at the site of maximum tenderness. The injection is performed as a single dose in one session using the Peppering method (3 injections of 1 ml). Intervention 2: Intervention group:  B: 20 ​​ml of blood is taken from the patient and PRP with a platelet concentration of 4-6 times the baseline is prepared using a single-stage centrifuge and the standard Alpha kit. After obtaining informed consent, PRP injection is performed by palpation at the site of maximum tenderness. Single-point method (one 3 ml injection) The injection is performed as a single dose in one session.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After deidentifying people, all the data obtained from the research, including the demographic information of the samples, clinical information and the results of the intervention can be shared.

When:
It is possible to access the results after nine to twelve months from the publication of the results.

To whom:
Researchers in academic centers and scientific research centers.

Conditions:
In order to data comparison in similar studies, the researchers of academic centers and scientific research centers have the possibility to receive data and re-analyze it if they comply with the principles of ethics in research.

Where to obtain:
Dr Amin Bakhshizadeh Imcheh with below email address:bakhshizadeh.dr@gmail.com and phone number:+989145339437

How to obtain:
Researchers should send a written request to receive data to the relevant email address.A week after receiving an email , it will take action.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amin Bakhshizadeh Imcheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Square</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417913191</zip>
        <telephone>+98 914 533 9437</telephone>
        <email>bakhshizadeh.dr@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amin Bakhshizadeh Imcheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab square</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417913191</zip>
        <telephone>+98 914 533 9437</telephone>
        <email>bakhshizadeh.dr@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-65 years, clinical diagnosis confirmed by a physician, failure to respond to conservative treatment, and ability to cooperate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of surgery within the last year for plantar fasciitis, injection therapy, laser or shockwave therapy within the last 2 months, and use of Plavix within the last week</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A:20 ml of blood is taken from the patient and PRP is prepared with a platelet concentration 4-6 times the baseline using a single-stage centrifuge and the standard Alpha kit. After obtaining informed consent, PRP is injected by palpation at the site of maximum tenderness. The injection is performed as a single dose in one session using the Peppering method (3 injections of 1 ml).</i_keyword>
      <i_keyword>Intervention group:  B: 20 ​​ml of blood is taken from the patient and PRP with a platelet concentration of 4-6 times the baseline is prepared using a single-stage centrifuge and the standard Alpha kit. After obtaining informed consent, PRP injection is performed by palpation at the site of maximum tenderness. Single-point method (one 3 ml injection) The injection is performed as a single dose in one session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination and comparison of the mean pain score (VAS) at 2 weeks and 12 weeks after injection in patients in intervention group A and intervention B-Determination and comparison of the foot functional status (FFI) score at 2 weeks and 12 weeks after injection in patients in intervention group A and intervention B-Determination and comparison of the incidence rate of various possible side effects after injection during follow-up in patients in intervention group A and intervention B-Determination and comparison of the mean pain score (VAS) and foot functional status (FFI) at the beginning of the study in patients in intervention group A and intervention B-Determination and comparison of the distribution of demographic and clinical characteristics at the beginning of the study in patients in intervention group A and intervention B. Timepoint: Change in mean pain intensity score based on the Visual Analogue Scale (VAS) from baseline (before injection) to 2 weeks and 12 weeks after PRP injection in the two peppering and single-point groups. Method of measurement: The Visual Analog Scale (VAS) will be used to assess the severity of patients' pain, and the Foot Function Index (FFI) questionnaire will be used to assess foot function. Scores for both instruments will be collected and recorded through direct patient questionnaires.Visual Analog Scale (VAS): This instrument is used to measure pain severity and is designed based on the Likert scale. In this scale, pain severity is reported as a number from 0 to 10, with 0 indicating complete absence of pain and 10 indicating the most severe pain imaginable.Foot Function Index (FFI): This questionnaire is used to assess the degree of foot dysfunction and consists of 17 questions categorized into three subscales: pain (5 questions), disability (9 questions), and mobility limitation (3 questions). Each question is scored numerically from 0 to 10. The final score for each subscale is calculated from the sum of the scores for its questions and determines the patient's level of pain, disability, and mobility limitation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-25</approval_date>
        <contact_name>Research Ethics Committee of Dr. Shariati Hospital Educational, Research and Treatment Center - Tehr</contact_name>
        <contact_address>Three ways of Jalal Al-Ahmad tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
