High Protein Oral Nutritional Support With Special Nutrients in Patients With Type 2 Diabetes and Foot Ulcer

Study Overview
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Brief Summary
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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

Official Title
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Effekt af højproteindrik Med særligt Udvalgte næringsstoffer Til Mennesker Med Type 2 Diabetes og fodsår

Conditions
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Healing Ulcer

Intervention / Treatment
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* Dietary Supplement: Cubitan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cubitan<br>2 x oral nutritional supplement daily | Dietary Supplement: Cubitan<br>* 2 bottles of Cubitan daily, for 12 weeks.<br>|
| No Intervention: Usual care<br>usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |