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Slow patient reqruitment
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cubitan | Experimental | 2 x oral nutritional supplement daily |
|
| Usual care | No Intervention | usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cubitan | Dietary Supplement | 2 bottles of Cubitan daily, for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| foot ulcer area | Reduction in ulcer area of the index ulcer, cm^2(based on height and width) within 12 weeks | 12 weeks |
| Foot ulcer healing | Time to complete healing | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to intervention | number of bottles ingested/bottles expected to ingest | 12 weeks |
| Accept of intervention | Measured by Visual Analogue Scale, minimum score 1, maximum score 5. Lower score is better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randi Tobberup, phd | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
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| 12 weeks |
| HbA1c | Change in HbA1c | 12 weeks and 6 months |
| Adverse events | number of adverse events in relation to hypo- or hyperglycemia, amputations, kidney function | 12 weeks and 6 months |
| Body weight | change in body weight | 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. | 12 weeks and 6 months |
| Number of foot ulcers | number of foot ulcers | 12 weeks and 6 months |
| Depth foot ulcer | Reduction in depth within 12 weeks | 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 | 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 | 6 months |
| Reduction in ulcer area | Reduction in ulcer area of the index ulcer, cm^2 (based on height and width) | 6 months |
| Number of new foot ulcers | Counting the number of new foot ulcers occuring after study inclusion | 12 weeks and 6 months |