None listed
Conditions
Brief summary
Diabetic foot ulcers are a common consequence of diabetes, which occur as a result of the vascular and neurological complications associated with the disease, as well as opportunistic infections and inadequate wound healing. The most recent prevalence estimates suggest that between 4 and 10% of individuals with diabetes have foot ulcers. Recent clinical research has focussed on the dietary conditionally essential amino acid arginine and its role in wound healing. Published research has shown that it offers a benefit in the healing of pressure ulcers (also known as bed sores). Little in the way of human studies using clinically relevant models examining the effect of arginine supplementation on diabetic foot ulcers have been conducted. If the same rate of diabetic foot ulcer healing can be achieved with arginine supplementation as seen with pressure ulcers, then this would have important management implications in treating this condition. This project aims to assess by means of a randomised-controlled trial, the healing rate of diabetic foot ulcers in patients with diabetes attending a hospital outpatient clinic who are consuming an arginine-containing nutritional supplement versus patients who are only receiving standard nutritional care.
Interventions
The intervention group will consume daily two sachets of a commercial arginine powder (Arginaid [Registered Trademark]; Nestle Medical Nutrition) giving a final dose (from the two sachets combined) of 9 grams of arginine, 310 mg of vitamin C, and 180 IU (81 mg) of vitamin E in total for a 4-week week period on top of their normal diet.
At baseline, and at weeks 2 and 4 corresponding to outpatient clinic visits, patients will have measurements of the foot ulcer size and depth taken as well as t
The intervention group will consume daily two sachets of a commercial arginine powder (Arginaid [Registered Trademark]; Nestle Medical Nutrition) giving a final dose (from the two sachets combined) of 9 grams of arginine, 310 mg of vitamin C, and 180 IU (81 mg) of vitamin E in total for a 4-week week period on top of their normal diet. At baseline, and at weeks 2 and 4 corresponding to outpatient clinic visits, patients will have measurements of the foot ulcer size and depth taken as well as their overall health status to assess the rate of healing over 6 weeks. Non-nutrition foot ulcer care will be kept constant during the study period according to standard clinic protocols.
Sponsors
Northern Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed