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

NCT ID: NCT05464407

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2023-03-31

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

Detailed Description

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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)

Conditions

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Healing Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Cubitan

2 x oral nutritional supplement daily

Group Type EXPERIMENTAL

Cubitan

Intervention Type DIETARY_SUPPLEMENT

2 bottles of Cubitan daily, for 12 weeks.

Usual care

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cubitan

2 bottles of Cubitan daily, for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Randi Tobberup

Head of clinical dietitians, Ph.d.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randi Tobberup, phd

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N20210057

Identifier Type: -

Identifier Source: org_study_id

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