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IRCT2015123018842N10 IRCT 2016-02-07 Hematology, Oncology and Stem Cell Transplantation Reseach Center Efficacy of platelet gel on diabetic foot ulcer Comparative study on effect of PRP-gel application and regular dressing on healing of diabetic wound 2013-04-20 anticipated 22 Complete https://irct.ir/trial/16974 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 3 Condition 1: Insulin-dependent diabetes mellitus. Condition 2: Non-insulin-dependent diabetes mellitus. Condition 3: Other specified diabetes mellitus. Condition 4: Unspecified diabetes mellitus. Dressing of ulcer with Autologous platelet rich plasma gel which is activated by cacl2 (2 ml/cm2 ) weekly up to full healing.
public Saeed Mohammadi
North Kargar St., Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2635 saeedm_58@yahoo.com Hematology, Oncology and Stem Cell Transplantation Resaerch Center scientific Kamran Alimoghaddam
North Kargar St., Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2635 alimgh@tums.ac.ir Hematology, Oncology and Stem Cell Transplantation Resech Center Iran (Islamic Republic of) Patients with chronic DFUs were enrolled in the study. Chronic DFU, considered as a wound in an extremity (mostly foot) of a known diabetic patient which has not decreased by 50% of the primary size in one month (Inclusion criteria). No other limitations such as age, sex, fasting blood sugar (FBS) or hemoglobin A1C (Hb A1C) levels were applied.Exclusion criteria included osteomyelitis, malignant arterial insufficiency, exposed bone in an ulcer, antibiotic resistance DFU, wounds with Charcot deformity, history of anti-proliferative medication or radiation in past 3 months, serum Hb<10 mg/dL, platelet count<103/μL and history of growth factor therapy within last 2 weeks. 35 years 65 years Both E10 E11 E13 E14 Insulin-dependent diabetes mellitus Non-insulin-dependent diabetes mellitus Other specified diabetes mellitus Unspecified diabetes mellitus Rehabilitation Dressing of ulcer with Autologous platelet rich plasma gel which is activated by cacl2 (2 ml/cm2 ) weekly up to full healing Ulcer size. Timepoint: weekly up to full healing. Method of measurement: Ruler. Efficacy of platelet gel on prevention of foot amputation. Timepoint: mounthly after strat treatment. Method of measurement: visit by surgeon. Hematology, Oncology and Stem Cell Transplantation Reseach Center Approved 2015-12-24 Hematology, Oncology and Stem Cell Transplantation Research Center North Kargar St., Shariat Hospital Tehran Iran (Islamic Republic of)