Diabetic foot ulcer. Peripheral angiopathy in diseases classified elsewhere. Diabetic peripheral angiopathy
Conditions
Interventions
Intervention 1: Intervention group: In addition to standard daily wound care, each patient will receive ANGIPARSTM one capsule, 120mg bid for 8 weeks and topical cream bid. The cream should be rubbed
Treatment - Drugs
Intervention group: In addition to standard daily wound care, each patient will receive ANGIPARSTM one capsule, 120mg bid for 8 weeks and topical cream bid. The cream should be rubbed around the wound
Control group: In control group patients will recieve only standard wound care
Sponsors
Pars Roos Biotechnology Co.
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 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound size. Timepoint: Begining, Weeks 2, 6, 8, 12 ,16 and 20. Method of measurement: Measurment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Syrian Arab Republic
Contacts
Public ContactDr. Faten Alakkad
Clinical trial Department
Outcome results
None listed