Effects of ANGIPARS in Diabetic Foot Ulcers

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 300

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

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.