Study design and participants
sepsis, hypovolemic, diabetes
PLATELET DISORDERS, SEPSIS, RECRUITMENT, DIABETES
This randomized, single-center, controlled, parallel clinical trial was carried out from February 2019 to January 2020. There were no important changes to methods after trial commencement.Eighteen eligible patients with confirmed CL were enrolled in this study, out of which 15 completed the trial. The study population consisted of adult male patients with CL referred to Ghafouri Specialized Laboratory in Jahrom, Iran.In the present study, all enrolled patients had more than one skin wound that involved the upper and lower limbs. Going for wounds of the same size and on the same limb, one of the wounds was randomly selected as the control and the other as the intervention wound.Age older than 15 years, and the presence of at least 2 wounds with the same dimensions on the hands and feet of the patients were considered as inclusion criteria. Also, hemoglobin < 10 mg/dl, qualitative and quantitative platelet disorders, abnormal screening tests, positive history of diabetes, positive history of severe hypovolemic conditions, sepsis, and anti-inflammation medications consumption during the past 2 weeks were defined as the exclusion criteria.After obtaining written consent and confirming that the prothrombin time (PT) and partial thromboplastin time (PTT) coagulation screening tests were within the normal range, 15 ml of citrated blood samples (once per week, up to 8 weeks) were taken from the patients. The recruitment and follow up flow of the participants is shown in a Consolidated Standards of Reporting Trials (CONSORT) diagram in Fig. CONSORT diagram showing flow of participants throughout the study