ACTRN12612000036819
Completed
未知
A randomised-controlled trial of oral arginine supplementation on the healing of foot ulcers in patients with type 2 diabetes
orthern Hospital0 sites8 target enrollmentStarted: January 9, 2012Last updated:
Overview
- Phase
- 未知
- Status
- Completed
- Sponsor
- orthern Hospital
- Enrollment
- 8
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •Study eligibility will include a confirmed diagnosis of Type 2 diabetes mellitus and a foot ulcer with an International Working Group of the Diabetic Foot (IWGDF) PEDIS classifications (as listed below) of at least 4 weeks duration.
- •1\.Perfusion: Grades 1\-3
- •2\.Depth: Grades 1\-3
- •3\.Infection: Grades 1\-3
- •4\.Sensation: Grades 1 and 2
Exclusion Criteria
- •Patients with a Grade 4 infection rating according to the IWGDF PEDIS classification system will be excluded as systemic signs will usually require hospital admission. Patients with phenylketonuria, sepsis, chronic renal failure, malignancy, and chronic inflammatory bowel disease, will be excluded for health and safety reasons. Individuals receiving hydroxyurea or greater than 10 mg prednisolone or 1\.5 mg dexamethasone per day will also be excluded as these drugs can impact on the rate of healing of diabetic foot ulcers. Individuals using insulin to manage their diabetes will also be excluded.
Investigators
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