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

Healing Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05464407
• Other study ID #: N20210057
• Status: Terminated
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Healing Ulcer
• Ulcer

Intervention

Dietary Supplement:
• Cubitan
2 bottles of Cubitan daily, for 12 weeks.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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