<?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>IRCT20260702070046N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-08</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of topical timolol on wound healing after fingertip amputation.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Topical Timolol on Wound Healing Following Fingertip Amputation: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91411</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Enrolled patients were randomised 1:1 to the timolol or control arm using a computer generated randomisation sequence in permuted blocks of four and six, Blinding description: This study was single-blind. Outcome assessors (clinicians performing wound inspection and two-point discrimination testing) were blinded to treatment allocation. However, patient blinding was not feasible due to the visible difference in the application method between topical timolol drops and normal saline drops.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Fingertip amputation (traumatic).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Timolol maleate ophthalmic solution 0.5%, two drops (approximately 50 μl per drop) were applied to the wound surface once daily. After application of the drops, the wound was covered with sterile Vaseline gauze. Patients or caregivers received complete instructions on how to apply the drops and change the dressing. Intervention 2: Control group: Standard wound care included two drops of normal saline on the wound and then a Vaseline gauze dressing with a non-adhesive layer similar to the intervention group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the single-center nature of the study, limited resources, and concerns regarding patient privacy and data confidentiality, there is no plan to share individual participant data (IPD) publicly.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Morteza Solati kooshkqazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bandar Lengeh, Imam Hossein Blvd., 3rd floor, Islamic Azad University Building, Bandar Lengeh Branch</address>
        <city>Bandar lengeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7971683355</zip>
        <telephone>+98 76 4422 1853</telephone>
        <email>mortezasolati1400@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morteza Solati kooshkqazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bandar Lengeh, Imam Hossein Blvd., 3rd floor, Islamic Azad University Building, Bandar Lengeh Branch</address>
        <city>Bandar lengeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7971683355</zip>
        <telephone>+98 76 4422 1853</telephone>
        <email>mortezasolati1400@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adults 18 years and older
A person visiting an emergency room or hand clinic with an amputated fingertip (second, third, or fourth finger)
Full thickness excision with soft tissue loss up to 1.5 x 1.5 cm2
Visiting a medical center within 24 hours of the injury
Ability to attend scheduled follow-up visits</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diabetes mellitus
Autoimmune diseases
Autoimmune diseases
Significant cardiovascular disease
Active smoking
Pregnancy or lactation
History of allergy or intolerance to beta-blockers
Concurrent use of systemic beta-blocker medication
Inability to give informed consent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T92.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>T92.6</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Timolol maleate ophthalmic solution 0.5%, two drops (approximately 50 μl per drop) were applied to the wound surface once daily. After application of the drops, the wound was covered with sterile Vaseline gauze. Patients or caregivers received complete instructions on how to apply the drops and change the dressing.</i_keyword>
      <i_keyword>Control group: Standard wound care included two drops of normal saline on the wound and then a Vaseline gauze dressing with a non-adhesive layer similar to the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to complete wound epithelialisation. Timepoint: Assessed daily after the second week until complete wound closure, with confirmation at scheduled visits (2 weeks, 1 month, and 4 months post-injury). Time was recorded in days from the date of injury. Method of measurement: Clinical confirmation by blinded assessor: intact epithelial coverage with no drainage and no need for further dressings.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Proportion of wounds completely healed. Timepoint: At 2 weeks, 1 month, and 4 months after injury. Method of measurement: Clinical assessment by blinded assessor for complete epithelial coverage with no drainage and no requirement for further dressings.</sec_outcome>
      <sec_outcome>Sensory recovery measured by static two-point discrimination. Timepoint: At 4 months after injury. Method of measurement: Static two-point discrimination test using a standardized aesthesiometer; the smallest distance at which two points were perceived as distinct was recorded in millimeters, with the contralateral uninjured fingertip as reference.</sec_outcome>
      <sec_outcome>Wound infection rate. Timepoint: Throughout the study period with particular attention at 2 weeks, 1 month, and 4 months. Method of measurement: Clinical criteria including traditional signs (abscess, cellulitis, purulent discharge) and additional indicators (delayed healing, malodour, friable granulation tissue, etc.).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-07</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz, Zand Street, Imam Hossein Square, Shiraz Medical School shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
