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

Not Applicable

Terminated

• Conditions: Healing Ulcer
• Interventions: Dietary Supplement: Cubitan

• Registration Number: NCT05464407
• Lead Sponsor: Aalborg University Hospital

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)

Study Timeline

• Study Start: 2022-02-24
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-19
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cubitan	Cubitan	2 x oral nutritional supplement daily

Primary Outcome Measures

Name	Time	Method
Foot ulcer healing	12 weeks	Time to complete healing
foot ulcer area	12 weeks	Reduction in ulcer area of the index ulcer, cm\^2(based on height and width) within 12 weeks

Secondary Outcome Measures

Name	Time	Method
HbA1c	12 weeks and 6 months	Change in HbA1c
Accept of intervention	12 weeks	Measured by Visual Analogue Scale, minimum score 1, maximum score 5. Lower score is better outcome
Number of foot ulcers	12 weeks and 6 months	number of foot ulcers
Depth foot ulcer	12 weeks	Reduction in depth within 12 weeks
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
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.
Reduction in ulcer area	6 months	Reduction in ulcer area of the index ulcer, cm\^2 (based on height and width)
Compliance to intervention	12 weeks	number of bottles ingested/bottles expected to ingest
Body weight	12 weeks and 6 months	change in body weight
Adverse events	12 weeks and 6 months	number of adverse events in relation to hypo- or hyperglycemia, amputations, kidney function
Time to complete healing of foot ulcer	6 months	Time to complete healing of foot ulcer; Time to complete heling of foot ulcer
Number of new foot ulcers	12 weeks and 6 months	Counting the number of new foot ulcers occuring after study inclusion

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark