Condition 1: Diabetic Foot Ulcer. Condition 2: Diabetic Foot Ulcer. Insulin-dependent diabetes mellitus, With peripheral circulatory complications Non-insulin-dependent diabetes mellitus, With peripheral circulatory complications
Conditions
Interventions
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
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 contro
Placebo, the same drug preparations contained inert substances, with the same dosage and administration route as intervention group in addition to standard wound care
Sponsors
Endocrinology and Metabolism Research Center(EMRC) of Tehran University of Medical Sciences
ParsRoos Company
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed