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IRCT138806111414N2 IRCT 2010-03-16 Endocrinology and Metabolism Research Center(EMRC) of Tehran University of Medical Sciences Effects of ANGIPARS in Diabetic Foot Ulcers ADFU Randomized Double-Blind Placebo-Controlled Trial of ANGIPARS (TM) in Diabetic Foot Ulcer 2010-08-01 anticipated 300 Complete https://irct.ir/trial/664 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Condition 1: Diabetic Foot Ulcer. Condition 2: Diabetic Foot Ulcer. Intervention 1: Angipars 1 capsule, 100 mg bid in addition to 3% topical cream bid for a period of 6 weeks in addition to standard wound care (glycemic control , debridement, dressing, offloading and infection control). Intervention 2: Placebo, the same drug preparations contained inert substances, with the same dosage and administration route as intervention group in addition to standard wound care.
public
scientific Larijani B
th Floor, Doctor Shariati Hospital, North Kargar St.
Tehran Iran (Islamic Republic of) 1411413137 +98 21882200378 emrc@tums.ac.ir Endocrinology and Metabolism Research Center of Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria •Diagnosis of Diabetes Mellitus (Type 1 or 2) defined by the American Diabetes Association criteria •Age equal or more than 18 years and less than 75 •Presence of one or more grade II or III foot ulcers based on the Wagner wound classification more than one square centimiter, for at least 2 weeks. Infection should be treated successfully prior to recruitment •Haemoglobin A1C less than 10% •Signing a written informed consent Exclusion criteria •Receiving any investigational drug within the last 30 days •Severe Peripheral Arterial Diseases (PAD), (Ankle Brachial Pressure index less than 0.5) •Any local or systemic signs of active infection including purulent discharge or marginal skin erythema (up to three centimetres from the margin of the wound) •Presence of acute osteomyelitis or exposed bone •Presence of any other systemic or chronic illness such as: oChronic hepatic diseases oChronic Kidney Diseases (GFR <60 ml/min per 1.73 m2) oClinically complicated pulmonary, cardiac, hematologic, gastrointestinal diseases, oAny other endocrine diseases other than DM oSerious psychological problems such as severe anxiety or depression •Malignancy •Pregnancy or intention to become pregnant during the study period (4.5 months) •Inability to give an informed consent •Corticosteroid therapy •Any drug hypersensitivity •Radiotherapy, Chemotherapy or the use of any immunosuppressive drugs •Electrolyte imbalance •Alcohol or substance misuse 18 years 75 years Both E10.5 E11.5 Insulin-dependent diabetes mellitus, With peripheral circulatory complications Non-insulin-dependent diabetes mellitus, With peripheral circulatory complications Treatment - Drugs Placebo Angipars 1 capsule, 100 mg bid in addition to 3% topical cream bid for a period of 6 weeks in addition to standard wound care (glycemic control , debridement, dressing, offloading and infection control) Placebo, the same drug preparations contained inert substances, with the same dosage and administration route as intervention group in addition to standard wound care Wound surface area. Timepoint: Baseline, weeks 2, 4, 6, 10, and 18. Method of measurement: To determine this outcome, a ruler will be placed at the wound margin and then digital photograph will be taken and the wound surface area will be determined using special software (Hakim Software) through planimetry methods. Ankle Brachial Index (ABI). Timepoint: Baseline, weeks 2, 4, 6, 10, and 18. Method of measurement: Ratio. Toe pressure. Timepoint: Baseline, weeks 2, 4, 6, 10, and 18. Method of measurement: mmHg(by fastening a small calf around the toe and measuring the capillary pressure by PPGI probe using arterial Doppler sonography). Wound bed temperature. Timepoint: Baseline, weeks 2, 4, 6, 10, and 18. Method of measurement: Centigrade(by DermaTemp). Patient Global Impression of Change (PGIC). Timepoint: Baseline, weeks 2, 4, 6, 10, and 18. Method of measurement: Through a 10-point scale (P&CGIC-Form). Quality of life. Timepoint: Baseline, weeks 2, 4, 6, 10, and 18. Method of measurement: SF-12 HEALTH SURVER (Iranian Version). Clinical Global Impression of Change (CGIC). Timepoint: Baseline, weeks 2, 4, 6, 10, and 18. Method of measurement: Through a 10-point scale(P&CGIC-Form). Clinical assessment of advers event. Timepoint: Baseline, weeks 2, 4, 6, 10, and 18. Method of measurement: Adverse Event Report Form. ParsRoos Company - - Endocrinology and Metabolism Research Center(EMRC) of Tehran University of Medical Sciences ParsRoos Company Approved 2009-08-15 Ethical Committee of Endocrinology & Metabolism Research Center 5th Floor, Doctor Shariati Hospital, North Kargar Avenue Tehran Iran (Islamic Republic of)