Determination of the effect of Autologous Platelet Gel on wound healing and repair of scars caused by cutaneous Leishmaniasis
Design
In this clinical trial, 15 patients entered the study according to entry requirements and randomly. In this clinical trial, a wound that received routine treatment in addition to the platelet gel, is compared with another wound on the patient's hand that received only routine treatment.This study is the third phase of the trial. In this intervention, platelet gel is used at 5 time points (Once a week) for each patient.
Settings and conduct
The place of the intervention is Jahrom University of Medical Sciences. In this study, the physician is blind to the type of treatment.
Participants/Inclusion and exclusion criteria
The subjects are patients with cutaneous leishmaniasis.
Entry requirements: Patients with cutaneous leishmaniasis , Age between 15 to 50 years old.
Non- entry: Hypovolemic states, Qualitative and quantitative platelet dysfunction, Sepsis, Diabet
Intervention groups
The intervention group consists of patients who have ulcers caused by cutaneous leishmaniasis with the entry conditions mentioned above, and in addition to routine treatment (glucantime), they will receive the autologous platelet gel product. The control group receive only routine treatment.
Main outcome variables
Duration of wound healing, Wound area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190212042694N1
Registration date:2019-02-20, 1397/12/01
Registration timing:registered_while_recruiting
Last update:2019-02-20, 1397/12/01
Update count:0
Registration date
2019-02-20, 1397/12/01
Registrant information
Name
Akbar Hashemi Tayer
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5434 0405
Email address
a.hashemi@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Autologous Platelet Gel on healing of cutaneous Leishmaniosis wounds
Public title
Effect of platelet gel on healing of leishmaniosis wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cutaneous leishmaniasis referring to health centers
Exclusion criteria:
Hypovolumic patients
Qualitative and quantitative Platelet disorders
Sepsis
Diabet
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
Patients with cutaneous Leishmaniasis usually have more than one ulcers that can be selected the control group and the case in one person.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are selected randomly
Randomization unit: Individual
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, clinical observant and outcome evaluator are not aware of the type of treatment given in each group and are actually Blind to those who received the platelet gel.
Placebo
Not used
Assignment
Parallel
Other design features
Patients are randomly assigned into two groups (control-case). The control group, are received the routine treatment and the case group, received a platelet gel in addition to the routine treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics
Street address
Jahrom university of medical sciences, Mothahri Ave, Jahrom city, Fars province
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2018-08-01, 1397/05/10
Ethics committee reference number
IR.JUMS.REC.1397.033
Health conditions studied
1
Description of health condition studied
Cutaneous Leishmaniosis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Size of the wound
Timepoint
Once a week after starting treatment, until the wound is completely healed
Method of measurement
Ruler
Secondary outcomes
1
Description
Determination of the Effect of Platelet Gel on Cutaneous Leishmaniasis Wound Healing
Timepoint
Once a week after starting treatment
Method of measurement
Patient examination by physician
Intervention groups
1
Description
Intervention group: Includes people with cutaneous Leishmaniasis and between 15 and 50 years of old. In this group, in addition to the routine treatment, the autologous platelet gel is used once a week until complete wound healing.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom University of Medical Sciences, Ghafori Lab
Full name of responsible person
Akbar Hashemi Tayer
Street address
Motahari Ave, Jahrom City, Fars Province, IRAN
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Fax
Email
hashemiakbar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavous Solhjo
Street address
Motahari Ave, Jahrom City, Fars Province, IRAN
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
sohjo@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Akbar Hashemi Tayer
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Medical Department, Jahrom University of Medicla Sciences, Motahari Ave, Jahrom City, Fars, IRAN
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
hashemiakbar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Akbar Hashemi Tayer
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Medical Department, Jahrom University of Medical Sciences, Motahari Ave, Jahrom City, Fars, IRAN
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
hashemiakbar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Akbar Hashemi Tayer
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Jahrom University of Medical Sciences, Motahari Ave, Jahrom City, Fars, IRAN
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
hashemiakbar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available