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Clinical Trials/IRCT138806111414N2
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

Sponsor
Endocrinology and Metabolism Research Center(EMRC) of Tehran University of Medical Sciences

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