Clinical Trial Protocol Iranian Registry of Clinical Trials

26 Sep 2021

Eﬀect of Autologous Platelet Gel on healing of cutaneous Leishmaniosis wounds

Protocol summary Registration date: 2019-02-20, 1397/12/01 Registration timing: registered_while_recruiting Study aim Determination of the effect of Autologous Platelet Gel on wound healing and repair of scars caused by cutaneous Last update: 2019-02-20, 1397/12/01 Leishmaniasis Update count: 0 Design Registration date In this clinical trial, 15 patients entered the study 2019-02-20, 1397/12/01 according to entry requirements and randomly. In this Registrant information clinical trial, a wound that received routine treatment in Name addition to the platelet gel, is compared with another Akbar Hashemi Tayer wound on the patient's hand that received only routine Name of organization / entity treatment.This study is the third phase of the trial. In this Country intervention, platelet gel is used at 5 time points (Once a Iran (Islamic Republic of) week) for each patient. Phone Settings and conduct +98 71 5434 0405 The place of the intervention is Jahrom University of Email address Medical Sciences. In this study, the physician is blind to [email protected] the type of treatment. Participants/Inclusion and exclusion criteria Recruitment status The subjects are patients with cutaneous leishmaniasis. Recruitment complete Entry requirements: Patients with cutaneous Funding source leishmaniasis , Age between 15 to 50 years old. Non- entry: Hypovolemic states, Qualitative and quantitative platelet dysfunction, Sepsis, Diabet Expected recruitment start date Intervention groups 2019-02-20, 1397/12/01 The intervention group consists of patients who have Expected recruitment end date ulcers caused by cutaneous leishmaniasis with the entry 2019-08-23, 1398/06/01 conditions mentioned above, and in addition to routine Actual recruitment start date treatment (glucantime), they will receive the autologous empty platelet gel product. The control group receive only Actual recruitment end date routine treatment. empty Main outcome variables Trial completion date Duration of wound healing, Wound area empty Scientific title General information Effect of Autologous Platelet Gel on healing of cutaneous Leishmaniosis wounds Reason for update Acronym Public title IRCT registration information Effect of platelet gel on healing of leishmaniosis wound IRCT registration number: IRCT20190212042694N1 Purpose

1 Treatment City Inclusion/Exclusion criteria Jahrom Inclusion criteria: Province Patients with cutaneous leishmaniasis referring to health Fars centers Postal code Exclusion criteria: 7414846199 Hypovolumic patients Qualitative and quantitative Approval date Platelet disorders Sepsis Diabet 2018-08-01, 1397/05/10 Age Ethics committee reference number From 15 years old to 50 years old IR.JUMS.REC.1397.033 Gender Both Health conditions studied Phase 3 Groups that have been masked 1

Care provider Description of health condition studied Outcome assessor Cutaneous Leishmaniosis ICD-10 code Sample size B55.1 Target sample size: 15 ICD-10 code description More than 1 sample in each individual Cutaneous leishmaniasis Number of samples in each individual: 2 Patients with cutaneous Leishmaniasis usually have more than one ulcers that can be selected the control group Primary outcomes and the case in one person. Randomization (investigator's opinion) 1 Randomized Randomization description Description In this study, patients are selected randomly Size of the wound Randomization unit: Individual Timepoint Blinding (investigator's opinion) Once a week after starting treatment, until the wound is Double blinded completely healed Blinding description Method of measurement In this study, clinical observant and outcome evaluator Ruler are not aware of the type of treatment given in each group and are actually Blind to those who received the platelet gel. Secondary outcomes Placebo Not used 1 Assignment Parallel Description Other design features Determination of the Eﬀect of Platelet Gel on Cutaneous Patients are randomly assigned into two groups (control- Leishmaniasis Wound Healing case). The control group, are received the routine Timepoint treatment and the case group, received a platelet gel in Once a week after starting treatment addition to the routine treatment. Method of measurement Patient examination by physician Secondary Ids empty Intervention groups

Ethics committees 1 Description 1 Intervention group: Includes people with cutaneous Ethics committee Leishmaniasis and between 15 and 50 years of old. In Name of ethics committee this group, in addition to the routine treatment, the Research Ethics autologous platelet gel is used once a week until Street address complete wound healing. Jahrom university of medical sciences, Mothahri Ave, Category Jahrom city, Fars province N/A

2 Recruitment centers Person responsible for general inquiries

Contact 1 Name of organization / entity Recruitment center Jahrom University of Medical Sciences Name of recruitment center Full name of responsible person Jahrom University of Medical Sciences, Ghafori Lab Akbar Hashemi Tayer Full name of responsible person Position Akbar Hashemi Tayer Assistant professor Street address Latest degree Motahari Ave, Jahrom City, Fars Province, IRAN Ph.D. City Other areas of specialty/work Jahrom Hematology Province Street address Fars Medical Department, Jahrom University of Medicla Postal code Sciences, Motahari Ave, Jahrom City, Fars, IRAN 7414846199 City Phone Jahrom +98 71 5434 0405 Province Fax Fars Email Postal code [email protected] 7414846199 Phone +98 71 5434 0409 Sponsors / Funding sources Email [email protected] 1 Sponsor Person responsible for scientiﬁc Name of organization / entity inquiries Jahrom University of Medical Sciences Full name of responsible person Contact Kavous Solhjo Name of organization / entity Street address Jahrom University of Medical Sciences Motahari Ave, Jahrom City, Fars Province, IRAN Full name of responsible person City Akbar Hashemi Tayer Jahrom Position Province Assistant professor Fars Latest degree Postal code Ph.D. 7414846199 Other areas of specialty/work Phone Hematology +98 71 5434 0405 Street address Email Medical Department, Jahrom University of Medical [email protected] Sciences, Motahari Ave, Jahrom City, Fars, IRAN Grant name City Grant code / Reference number Jahrom Is the source of funding the same sponsor Province organization/entity? Fars Yes Postal code Title of funding source 7414846199 Jahrom University of Medical Sciences Phone Proportion provided by this source +98 71 5434 0409 100 Email Public or private sector [email protected] Public Domestic or foreign origin Person responsible for updating data Domestic Category of foreign source of funding Contact empty Name of organization / entity Country of origin Jahrom University of Medical Sciences Type of organization providing the funding Full name of responsible person Academic Akbar Hashemi Tayer

3 Position Deidentiﬁed Individual Participant Data Set (IPD) Assistant professor Undecided - It is not yet known if there will be a plan to Latest degree make this available Ph.D. Study Protocol Other areas of specialty/work Undecided - It is not yet known if there will be a plan to Hematology make this available Street address Statistical Analysis Plan Jahrom University of Medical Sciences, Motahari Ave, Undecided - It is not yet known if there will be a plan to Jahrom City, Fars, IRAN City make this available Jahrom Informed Consent Form Province Undecided - It is not yet known if there will be a plan to Fars make this available Postal code Clinical Study Report 7414846199 Undecided - It is not yet known if there will be a plan to Phone make this available +98 71 5434 0409 Analytic Code Email Undecided - It is not yet known if there will be a plan to [email protected] make this available Data Dictionary Sharing plan No - There is not a plan to make this available