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IRCT2014060415574N3 IRCT 2014-11-19 Vice chancellor for research, Kashan University of Medical Sciences Effect of platelet dressing on wound healing in diabetic foot Effect of platelet dressing on the healing of diabetic foot ulcers compared with routine dressing in patients with diabetic foot ulcers Shahid Beheshti Hospital 2014-07-23 anticipated 60 Complete https://irct.ir/trial/14801 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Diabetic foot ulcers. Intervention 1: 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. Intervention 2: 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.
public Mohammad Afshar
5th of Qotb –e Ravandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 8715164355 +98 31 5554 0021 afshar_m_1343@yahoo.com; mohammad.afshar@modares.ac.ir Kashan University of Medical Sciences scientific Mohammad Afshar
5th of Qotb –e Ravandi Blvd, Kashan
kashan Iran (Islamic Republic of) 8715164355 +98 31 5554 0021 afshar_m_1343@yahoo.com; mohammad.afshar@modares.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both E10, E11, With peripheral circulatory complications Treatment - Other Treatment - Drugs 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. 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. Platelet dressing. Timepoint: Days 1, 7, 14 and 21. Method of measurement: by checklist. 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. Wound healing. Timepoint: Days 1, 7, 14 and 21. Method of measurement: by the Checklist. Depth of wound. Timepoint: Days 1, 7, 14 and 21. Method of measurement: Measure the depth by the Measurements and record in the Checklist. During wound healing. Timepoint: Days 1, 7, 14 and 21. Method of measurement: by the Checklist. Vice chancellor for research, Kashan University of Medical Sciences Approved 2014-07-23 Ethics Committee for Kashan University of Medical Sciences 5th of Qotb– e Ravandi Blvd, Kasha Kashan Iran (Islamic Republic of)