To assess the supplement of a high protein oral nutritional supplement enriched with arginin, zink, vitamin c and antioxidants on the healing of foot ulcers in patients with type 2 diabetes mellitus
The intervention group receive 2 x ONS drink daily (total 2 x 200 kcal, 3 g arginin, 250 ml vitamin C, 38 mg vitamin e, 64 micr.g selenium, 9 mg zink)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
6
2 bottles of Cubitan daily, for 12 weeks.
Aalborg University Hospital
Aalborg, Denmark
foot ulcer area
Reduction in ulcer area of the index ulcer, cm\^2(based on height and width) within 12 weeks
Time frame: 12 weeks
Foot ulcer healing
Time to complete healing
Time frame: 12 weeks
Compliance to intervention
number of bottles ingested/bottles expected to ingest
Time frame: 12 weeks
Accept of intervention
Measured by Visual Analogue Scale, minimum score 1, maximum score 5. Lower score is better outcome
Time frame: 12 weeks
HbA1c
Change in HbA1c
Time frame: 12 weeks and 6 months
Adverse events
number of adverse events in relation to hypo- or hyperglycemia, amputations, kidney function
Time frame: 12 weeks and 6 months
Body weight
change in body weight
Time frame: 12 weeks and 6 months
Improvement in Quality of life
World Health Organisation - Five Well-Being Index (WHO 5). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Time frame: 12 weeks and 6 months
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Number of foot ulcers
number of foot ulcers
Time frame: 12 weeks and 6 months
Depth foot ulcer
Reduction in depth within 12 weeks
Time frame: 12 weeks
Classifying/scoring of food ulcer
Use of SINBAD (site-ischemia-neuropathy-bacterial infection-area-depth) score system. Minimum score 0, maximum score 6. Lower score is better outcome
Time frame: 12 weeks and 6 months
Time to complete healing of foot ulcer
Time to complete healing of foot ulcer Time to complete heling of foot ulcer
Time frame: 6 months
Reduction in ulcer area
Reduction in ulcer area of the index ulcer, cm\^2 (based on height and width)
Time frame: 6 months
Number of new foot ulcers
Counting the number of new foot ulcers occuring after study inclusion
Time frame: 12 weeks and 6 months