NCT05464407

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

April 22, 2022

Last Update Submit

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

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:

  • 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.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Study Officials

  • Randi Tobberup, phd

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

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

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)