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

Primary Purpose

Healing Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cubitan
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healing Ulcer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aalborg University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cubitan

Usual care

Arm Description

2 x oral nutritional supplement daily

usual care

Outcomes

Primary Outcome Measures

foot ulcer area
Reduction in ulcer area of the index ulcer, cm^2(based on height and width) within 12 weeks
Foot ulcer healing
Time to complete healing

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2022
Last Updated
July 18, 2022
Sponsor
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05464407
Brief Title
High Protein Oral Nutritional Support With Special Nutrients in Patients With Type 2 Diabetes and Foot Ulcer
Official Title
Effekt af højproteindrik Med særligt Udvalgte næringsstoffer Til Mennesker Med Type 2 Diabetes og fodsår
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healing Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
113 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cubitan
Arm Type
Experimental
Arm Description
2 x oral nutritional supplement daily
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Dietary Supplement
Intervention Name(s)
Cubitan
Intervention Description
2 bottles of Cubitan daily, for 12 weeks.
Primary Outcome Measure Information:
Title
foot ulcer area
Description
Reduction in ulcer area of the index ulcer, cm^2(based on height and width) within 12 weeks
Time Frame
12 weeks
Title
Foot ulcer healing
Description
Time to complete healing
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Compliance to intervention
Description
number of bottles ingested/bottles expected to ingest
Time Frame
12 weeks
Title
Accept of intervention
Description
Measured by Visual Analogue Scale, minimum score 1, maximum score 5. Lower score is better outcome
Time Frame
12 weeks
Title
HbA1c
Description
Change in HbA1c
Time Frame
12 weeks and 6 months
Title
Adverse events
Description
number of adverse events in relation to hypo- or hyperglycemia, amputations, kidney function
Time Frame
12 weeks and 6 months
Title
Body weight
Description
change in body weight
Time Frame
12 weeks and 6 months
Title
Improvement in Quality of life
Description
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.
Time Frame
12 weeks and 6 months
Title
Number of foot ulcers
Description
number of foot ulcers
Time Frame
12 weeks and 6 months
Title
Depth foot ulcer
Description
Reduction in depth within 12 weeks
Time Frame
12 weeks
Title
Classifying/scoring of food ulcer
Description
Use of SINBAD (site-ischemia-neuropathy-bacterial infection-area-depth) score system. Minimum score 0, maximum score 6. Lower score is better outcome
Time Frame
12 weeks and 6 months
Title
Time to complete healing of foot ulcer
Description
Time to complete healing of foot ulcer Time to complete heling of foot ulcer
Time Frame
6 months
Title
Reduction in ulcer area
Description
Reduction in ulcer area of the index ulcer, cm^2 (based on height and width)
Time Frame
6 months
Title
Number of new foot ulcers
Description
Counting the number of new foot ulcers occuring after study inclusion
Time Frame
12 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randi Tobberup, phd
Phone
+45 97663570
Email
r.tobberup@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lotte Boa, MSc
Phone
+4597663549
Email
losk@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randi Tobberup, phd
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randi Tobberup, phd
Phone
+4597663570
Email
r.tobberup@rn.dk
First Name & Middle Initial & Last Name & Degree
Lotte Boa, MSc
Phone
+4597663549
Email
losk@rn.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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