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IRCT2017080935600N1 IRCT 2017-08-15 Endocrinology and Metabolism Research Institute Effectiveness of hospital-based home care compared to hospital-based care for diabetic foot patients Hospital-based home care compared to hospital-based care Effectiveness of hospital-based home care compared to hospital-based care for diabetic foot patients on their quality of life and duration of wound healing in Shariati hospital 2016-04-20 anticipated 120 Complete https://irct.ir/trial/26855 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Diabetic Foot Ulcer. Intervention 1: Treatment of patients under intervention is continued in their home, having their family support, by a company licensed by Iran’s Ministry of Health, consisting of specialized physician(s) and nurse(s). The patients’ home care process is monitored and controlled by the study group through direct observation in patients home, 2 times a week (according to the timetable of the study). Patients will receive the treatment according to the clinical guidelines for wound management in diabetic foot ulcers approved by the endocrinology and metabolism research center. Intervention 2: Patients in the control group receive usual care in hospital.
public Zhila Najafpour
Economic And Health Management group, Public Health Faculty, Tehran University of Medical Sciences, Pour Sina street, Keshavarz boulevard, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8490 2101 zh-najafpour@razi.tums.ac.ir; zhila.najafpoor@gmail.com Tehran University of Medical Sciences scientific Dr. Mohamadreza Jafary
Shariati hospital, at the begining of Jalale Al Ahmad avenue, Kargar's north street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713137 +98 21 8490 2101 mrezajafary@yahoo.com, mr-jafary@farabi.tums.ac.ir Shariati Hospital Iran (Islamic Republic of) Inclusion criteria: the patient has given informed consent to participate within the study; the patient has a primary diagnosis of DF (stage 2,3,4 and ABI >0.5); the patient’s physician must agree that the patient is suitable for early discharge to HBHC; possibility to reside in Tehran, Iran. Exclusion criteria: unstable patient; the patient’s physician order that the patient should be transport to hospital; the patient hasn’t given informed consent. 12 years no limit Both E10.5 Diabetes mellitus with peripheral circulatory complications Treatment - Other N/A Treatment of patients under intervention is continued in their home, having their family support, by a company licensed by Iran’s Ministry of Health, consisting of specialized physician(s) and nurse(s). The patients’ home care process is monitored and controlled by the study group through direct observation in patients home, 2 times a week (according to the timetable of the study). Patients will receive the treatment according to the clinical guidelines for wound management in diabetic foot ulcers approved by the endocrinology and metabolism research center. Patients in the control group receive usual care in hospital Duration of wound healing. Timepoint: One mounth after intervention. Method of measurement: Patient interview, screening of medical record. Length of stay. Timepoint: 18 mounths after intervention. Method of measurement: Screaning of patient record. Patient quality of life. Timepoint: 18 mounths after intervention. Method of measurement: Patient interview. Level of HbA1c. Timepoint: 18 mounths after intervention. Method of measurement: Screaning of patient record. Rate of patient satisfaction. Timepoint: One mounth after intervention. Method of measurement: patient interview. Rate of amputation. Timepoint: 18 mounths after intervention. Method of measurement: Patient visit and screening of medical record. Endocrinology and Metabolism Research Institute Approved 2016-03-02 Ethics Committe in Resarech afiilated of Endocrinology and Metabolism Research Institute Endocrinology and Metabolism Research Institute, Shariati hospital, at the begining of Jalale Al Ahmad avenue, Kargar's north street, Tehran, Iran Tehran Iran (Islamic Republic of)