Phase II clinical trial of Angipars in patients with diabetic foot ulcer in Syria

Phase 2

• Conditions: Diabetic foot ulcer.; Peripheral angiopathy in diseases classified elsewhere. Diabetic peripheral angiopathy

• Registration Number: IRCT201102204272N2
• Lead Sponsor: Pars Roos Biotechnology Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Diagnosis of Diabetes Mellitus (Type 1 or 2) defined by American Diabetes Association criteria for at least 3 years; Presence of diabetic foot ulcer for a minimum duration of 1 months due to various reasons such as peripheral neuropathy, foot deformity, trauma or inappropriate shoes' limitation of activity, uncontrolled blood glucose, long term diabetes mellitus, etc.;
Wound size more than 2 cm squared;
Age more than 18 and less than 75;
Exclusion criteria:
Presence of acute infection of the ulcer with or without pus drainage or erythema of the ulcer margins of 3 cm width; Presence of wound with visible bone or signs suggestive of acute osteomyelitis; Presence of severe cardiac condition with functional class of 3 or higher or under treatment; Presence of signs and symptoms suggestive of severe and chronic ischemia with absence of peripheral pulses (absence of peripheral pulse alone is not an exclusion criteria); Any concurrent diseases or conditions which delay wound healing (cancer, vasculitis, ect.); Drug and alcohol abuse; Presence of chronic renal failure on hemodialysis or peritoneal dialysis; Treatment with corticosteroids, immune suppressants, radiotherapy or chemotherapy; Any known drug hypersensitivity; Inability or refusal to sign the informed consent; Receiving any investigational drug within 30 days prior to screening; Pregnancy or intention of becoming pregnant during the study period.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound size. Timepoint: Begining, Weeks 2, 6, 8, 12 ,16 and 20. Method of measurement: Measurment.

Secondary Outcome Measures

Name	Time	Method
Wound closure. Timepoint: Begining, Weeks 2, 6, 8, 12 ,16 and 20. Method of measurement: examination.;Ankle-Brachial Pressure Index. Timepoint: Begining, Weeks 2, 6, 8, 12 ,16 and 20. Method of measurement: Examination.;Quality of life. Timepoint: Begining, Weeks 2, 6, 8, 12 ,16 and 20. Method of measurement: Filling the questionaire.;Patient Global Impression of Change. Timepoint: Weeks 2, 6, 8, 12 ,16 and 20. Method of measurement: Interview.;Physician Global Impression of Change. Timepoint: Weeks 2, 6, 8, 12 ,16 and 20. Method of measurement: Physicians evaluation.