ACTRN12610000565044
Not yet recruiting
Phase 2
Pilot Clinical Trial for Treatment of Diabetic Foot Ulcers with Dietary Nano-formulated Phytochemicals in Mediterranean and Middle eastern Males suffering from Type 2 Diabetes with diabetic foot syndrome.
CamMedica, Ltd.0 sites35 target enrollmentJuly 13, 2010
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- diabetic foot ulcers
- Sponsor
- CamMedica, Ltd.
- Enrollment
- 35
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Mediterranean and Middle Eastern males, age 18\-65 (inclusive) suffering from Type 2 Diabetes with diabetic foot syndrome (1 and 2 grade Wagner scale) with body weight between 60\-80 kg.
- •Stable metabolic and glycemic control during last three months of disease and during trial period.
- •Foot ulcer aged at least two weeks sized 0\.5\-2\.0 cm.
Exclusion Criteria
- •Any foot ulceration not related to type 2 diabetes
- •Diabetic foot syndrome graded above 2 on Wagner's scale.
- •Kidney abnormalities requiring medical intervention.
- •Infectious complications of diabetic foot syndrome.
- •Critical abnormalities of blood circulation in affected limb.
Outcomes
Primary Outcomes
Not specified
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