IRCT138806111414N2CompletedPhase 3
Randomized Double-Blind Placebo-Controlled Trial of ANGIPARS (TM) in Diabetic Foot Ulcer
Endocrinology and Metabolism Research Center(EMRC) of Tehran University of Medical Sciences0 sites300 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 75 years (—)
- Sex
- All
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
Investigators
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