Healing Ulcer
Conditions
Brief summary
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
Detailed description
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)
Interventions
DIETARY_SUPPLEMENTCubitan
2 bottles of Cubitan daily, for 12 weeks.
Sponsors
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes with newly diagnosed foot ulcer * accept study participation
Exclusion criteria
* HbA1c \>90 mmol/L * cognitive challenges, fx dementia * history with known alcohol or drug abuse * allergy to milk or soya * home less * critical ischemia, distal blood pressure \<0.30 * EGFR \< 30 * dialysis or planned dialysis or patients with terminal kidney insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| foot ulcer area | 12 weeks | Reduction in ulcer area of the index ulcer, cm\^2(based on height and width) within 12 weeks |
| Foot ulcer healing | 12 weeks | Time to complete healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 weeks and 6 months | Change in HbA1c |
| Adverse events | 12 weeks and 6 months | number of adverse events in relation to hypo- or hyperglycemia, amputations, kidney function |
| Body weight | 12 weeks and 6 months | change in body weight |
| Improvement in Quality of life | 12 weeks and 6 months | 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. |
| Number of foot ulcers | 12 weeks and 6 months | number of foot ulcers |
| Compliance to intervention | 12 weeks | number of bottles ingested/bottles expected to ingest |
| Classifying/scoring of food ulcer | 12 weeks and 6 months | Use of SINBAD (site-ischemia-neuropathy-bacterial infection-area-depth) score system. Minimum score 0, maximum score 6. Lower score is better outcome |
| Time to complete healing of foot ulcer | 6 months | Time to complete healing of foot ulcer Time to complete heling of foot ulcer |
| Reduction in ulcer area | 6 months | Reduction in ulcer area of the index ulcer, cm\^2 (based on height and width) |
| Number of new foot ulcers | 12 weeks and 6 months | Counting the number of new foot ulcers occuring after study inclusion |
| Depth foot ulcer | 12 weeks | Reduction in depth within 12 weeks |
| Accept of intervention | 12 weeks | Measured by Visual Analogue Scale, minimum score 1, maximum score 5. Lower score is better outcome |
Countries
Denmark
Outcome results
None listed