None listed
Conditions
Brief summary
Diabetes is a multi-factorial disease, with a multi-disciplinary approach being advocated for diabetes treatment and the prevention of its complications. In Australia, diabetes is the most common cause of lower limb amputation after trauma. Diabetic foot ulcers are responsible for a substantial medical and financial burden on the Australian healthcare system with costs conservatively estimated to be as high as $45,000 per patient. Improved nutritional status and nutrition supplementation accelerate wound healing while inadequate nutrition prolongs wound healing. During wound healing non-essential amino acids, such as L-Arginine, becomes essential as it enhances a number of pathways involved in wound healing, protein metabolism, such as structural protein synthesis and collagen. Aim: To determine whether supplementation with L-Arginine will improve the healing of diabetic foot ulcers in a routine community based client education and management program conducted by medical and allied health professionals. Methods: This study is being designed as a double blinded RCT (treatment group: n=37+7, 4.5g L-arginine; control group n=19+7 placebo) for 12 weeks. Power calculations indicate 70 patients are required to provide adequate statistical power including anticipated attrition rate. The study will be conducted in a routine community based client education and management setting which includes health professionals (medical, podiatry, dietetic, diabetes educators) as part of a multi-disciplinary approach and holistic care for the client
Interventions
Arm 1 (intervention group) will be provided with 4.5 gms of L-Arginine powder per day for 12 weeks orally. The powder can be mixed with water
Sponsors
Australian Diabetes Educators Association
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Free living clients over the age of 18 yrs, attending the Townsville Community Health Services Clients with Type 2 Diabetes Clients with diabetic foot ulcers
Exclusion criteria
Clients under the age of 18 Pregnant women Clients with food allergies and intolerances Clients who are on Renal Dialysis Clients who have had a fracture, within 3 months of the start of the trial Clients who have been diagnosed with cirrhosis of the liver had burns to 10% or more of his/her body, within 6 months of the start of the trial. Clients who have suffered a heart attack, within 3 months of the start of the trial. Clients who have been scheduled for surgery within two weeks of the start of the trial or during the trial Clients who have low blood pressure. Women who are pregnant and/or breast feeding
Outcome results
None listed