NCT05464407

Terminated

High Protein Oral Nutritional Support With Special Nutrients...

Aalborg University Hospital Source

Aalborg University Hospital

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

N20210057

Study Type

interventional

Actual enrollment (reported)

6

Locations

1 country

Sites

1

Timeline

Study Start

February 24, 2022

Actual (reported)

Primary Completion

March 31, 2023

Actual (reported)

Study Completion

March 31, 2023

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 6 participants
Study completion date: March 31, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 24, 2022
Actual (reported)
First Submitted
April 22, 2022
Actual (reported)
First Posted
July 19, 2022
Actual (reported)
Primary Completion
March 31, 2023
Actual (reported)
Study Completion
March 31, 2023
Actual (reported)

Last Updated: January 31, 2024
Status Verified: January 2024
Last Update Submitted: January 30, 2024

Conditions

Healing Ulcer

Outcome Measures

Primary Outcomes (2)

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 Outcomes (12)

Compliance to intervention
12 weeks
Accept of intervention
12 weeks
HbA1c
12 weeks and 6 months
Adverse events
12 weeks and 6 months
Body weight
12 weeks and 6 months
+7 more secondary outcomes

Study Arms (2)

Cubitan

EXPERIMENTAL

2 x oral nutritional supplement daily

Dietary Supplement: Cubitan

Usual care

NO INTERVENTION

usual care

Interventions

CubitanDietary supplement

2 bottles of Cubitan daily, for 12 weeks.

Cubitan

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

type 2 diabetes with newly diagnosed foot ulcer
accept study participation

You may not qualify if:

Sponsors & Collaborators

Aalborg University Hospital
Otherlead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Study Officials

Randi Tobberup, phd
Aalborg University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Head of clinical dietitians, Ph.d.

Study Record Dates

First Submitted

April 22, 2022

First Posted

July 19, 2022

Study Start

February 24, 2022

Actual (reported)

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

Contact the study team to confirm eligibility.

Primary Completion

March 31, 2023

Actual (reported)

Study Completion

March 31, 2023

Actual (reported)

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05464407
Data provider: ClinicalTrials.gov
Source updated: 2024-01-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:59 UTC

Locations

DK(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Study Arms (2)

Cubitan

Usual care

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Study Arms (2)

Cubitan

Usual care

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations