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

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

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

Study Overview

• Status: Terminated
• Conditions: Healing Ulcer
• Intervention / Treatment: Dietary supplement: Cubitan

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; usual care
Experimental: Cubitan; 2 x oral nutritional supplement daily	Dietary supplement: Cubitan; 2 bottles of Cubitan daily, for 12 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Randi Tobberup, phd, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer
• Other Study ID Numbers: N20210057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No