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

Aalborg University Hospital

Status: Terminated

Conditions: Healing Ulcer

Treatments: Dietary Supplement: Cubitan

Study type: Interventional

Funder types: Other

Identifiers

NCT05464407

N20210057

Details and patient eligibility

About

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

Full 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)

Enrollment: 6 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups

Cubitan

Experimental group

Description:

2 x oral nutritional supplement daily

Treatment:

Dietary Supplement: Cubitan

Usual care

No Intervention group

Description:

usual care