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Effect of platelet dressing on the healing of diabetic foot ulcers compared with routine dressing in patients with diabetic foot ulcers Shahid Beheshti Hospital

Protocol summary

Summary
(1) Objectives, The overall aims are Examines the impact of platelet dressing on the healing of diabetic foot ulcers compared with routine dressing. (2) Design, The study design is a randomized clinical trial. (3) Setting and conduct, after referring patients with diabetic foot ulcers and checked by an infectious, qualified Patients for the study are selected and divided into two groups of case and control. For the treatment group, after the preparation of platelet from the patients blood, a platelet dressing will be done with 5 cc platelet rich plasma. This dressing will be removed from after three days followed by a simple normal saline dressing just the same as control group. Pictures will be taken on days 1, 7, 14 and 21 and finally the weight of the wound is calculated using software. A metal measure will be used to evaluate the depth of the wound and results will be monitored in the checklist. For the control group, dressing will also be done every day with normal saline. Finally Changes in the wounds as well as their depth and time of improvement will be calculated and compared (4). Inclusion criteria involves those with foot ulcer in the first or second Wagner phase, patients with equal number of platelet or more than 100,000, patient with HG at least 10, patients without clotting problems, and patients without immune suppressor medicine.(5) Interferences include wound debridement, blood sampling, dressing the wound with platelet rich gauze and dressing change(6). Variables are as platelet dressing (as independent) and wound depth and time of wound healing will be the dependent variables

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014060415574N3
Registration date: 2014-11-19, 1393/08/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-19, 1393/08/28
Registrant information
Name
Mohammad Afshar
Name of organization / entity
Medical kashan
Country
Iran (Islamic Republic of)
Phone
+98 31 5557 0278
Email address
mohammad.afshar@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Project costs will be paid by the Vice chancellor for research, kashan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of platelet dressing on the healing of diabetic foot ulcers compared with routine dressing in patients with diabetic foot ulcers Shahid Beheshti Hospital
Public title
Effect of platelet dressing on wound healing in diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diabetic patients with foot ulcers who entered is stage 1 or 2 foot ulcers؛ Patients with a platelet count equal to or greater than 100,000؛ Patients who have a minimum of 10 HB؛ Not taking medications that suppress the immune system; Patients who have no known clotting problems. exclusion criteria: Signs of sepsis in patients
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee for Kashan University of Medical Sciences
Street address
5th of Qotb– e Ravandi Blvd, Kasha
City
Kashan
Postal code
87135/1416
Approval date
2014-07-23, 1393/05/01
Ethics committee reference number
9321

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcers
ICD-10 code
E10, E11,
ICD-10 code description
With peripheral circulatory complications

Primary outcomes

1

Description
Platelet dressing
Timepoint
Days 1, 7, 14 and 21
Method of measurement
by checklist

Secondary outcomes

1

Description
Wound area
Timepoint
Days 1, 7, 14 and 21
Method of measurement
Calculate the area of ​​the wound, through the Photo And its analysis software and recorded by the Checklist of wound

2

Description
Wound healing
Timepoint
Days 1, 7, 14 and 21
Method of measurement
by the Checklist

3

Description
Depth of wound
Timepoint
Days 1, 7, 14 and 21
Method of measurement
Measure the depth by the Measurements and record in the Checklist

4

Description
During wound healing
Timepoint
Days 1, 7, 14 and 21
Method of measurement
by the Checklist

Intervention groups

1

Description
Intervention group: in intervention group Samples are selected among the diabetic patients with foot wound diagnosed by the infection disease specialist at Shahid Beheshti hospital in the first or second Wagner scale. Patients will be examined for the eligibility for using platelet treatment. Patient will be divided in two groups (treatment– control) and treatment group will be informed regarding to their treatment procedures. At the first phase, demographic data will be gathered about the wound and results of blood tests in two separated checklists .debridement will be done for each case if needed. For the treatment group, after disinfection of the cubital fossa, 50 cc of blood will be drown gathered in falcon sterile tubes. Samples are centrifuged for 200r/m for 20 minutes. Then the PRP will be gathered and transferred to another tube. For all samples, platelets are calculated and 100,000 concentrations will be prepared. Those with lower platelet count will be excluded. After preparing the PRP, 5 cc of it will be used for wound dressing using a 5 cc syringe we pour the PRP on the sterile gauze ant put it on the wound covering with sterile gauze. This PRP dressing will remain for 3 days on the wound. After that, other wounds will be dressed by normal saline and wounds will be evaluated on days 7, 14 and 21 by a digital camera that gets pictures from the wounds from 30 cm distance. The weight of the wounds will be assessed by software and their depth will be evaluated using a metal measure. Finally all registered data will be compared in treatment and control groups.
Category
Treatment - Other

2

Description
control groups: First, patients with diabetic foot ulcers who are stage 1 or 2 according to Wagner have been examined by a specialist in infectious And qualify for inclusion in the need for surgical debridement for their advice is requested.After debridement, the wound was irrigated with normal saline and sterile gauze dressing is routine. Dressing change on a daily basis will be the control group.Dressing change on a daily basis will be the control group.In this group, such as group therapy and depth of the wound area on days 1, 7, 14 and 21 measured And changes in the size and depth of the wound area in the two groups were compared with each other.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti hospital, Kashan
Full name of responsible person
Mohammad Afshar
Street address
Beheshti hospital, 5th of Qotb –e Ravandi Blvd, Kashan
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
5th of Qotb –e Ravandi Blvd, Kashan
City
Kashan
Grant name
Grant code / Reference number
9321
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
Masters/Lecturer
Other areas of specialty/work
Street address
5th of Qotb –e Ravandi Blvd, Kashan
City
Kashan
Postal code
8715164355
Phone
+98 31 5554 0021
Fax
+98 31 5554 8882
Email
afshar_m_1343@yahoo.com; mohammad.afshar@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
Masters
Other areas of specialty/work
Street address
5th of Qotb –e Ravandi Blvd, Kashan
City
kashan
Postal code
8715164355
Phone
+98 31 5554 0021
Fax
+98 315558882
Email
afshar_m_1343@yahoo.com; mohammad.afshar@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
Masters/Lecturer
Other areas of specialty/work
Street address
5th of Qotb –e Ravandi Blvd, Kashan
City
kashan
Postal code
8715164355
Phone
+98 31 5554 0021
Fax
+98 315558882
Email
afshar_m_1343@yahoo.com; mohammad.afshar@modares.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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