UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study for effect of oral nutrition supplement on pressure ulcer healing
Title of the study (Brief title)	Study for the nutrition supplement on pressure ulcer healing
Region	Japan

Condition
Condition	Pressure ulcer
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the relationship between nutrition and pressure ulcer healing by evaluatiopn the intake of oral nutrition supplements and nutritional status of the patients with pressure ulcer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of pressure ulcer healing assessed by DESIGN-R score
Key secondary outcomes	a. The rate of nutritional improvement assessed by CONUT score b. Feasibility of oral nutritional supplements

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Manageable pressure ulcer 2. Suppliable oral nutrition supplements 3. Hospital stay more than 2 weeks
Key exclusion criteria	1. Unmanageable pressure ulcer 2. Unable to supply oral nutrition supplements 3. Hospital stay within 2 weeks 4. Intubation at enrollment 5. Under 20 year old
Target sample size	100

Research contact person
Name of lead principal investigator	Fuyuhiko Motoi
Organization	Tohoku University
Division name	Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7205
Email	fmotoi@surg1med.tohoku.ac.jp

Public contact
Name of contact person	Fuyuhiko Motoi
Organization	Tohoku University
Division name	Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7205
Homepage URL	http://www.med.tohoku.ac.jp/public/ekigaku.html
Email	fmotoi@surg1.med.tohoku.ac.jp

Sponsor
Institute	Nutrition Support Center and Wound Ostomy Continence (WOC) Center, Nursing Department of Tohoku University Hospital
Institute
Department

Funding Source
Organization	Department of Surgery, Tohoku University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 19 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 08 Month 19 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design: Cohort study (Observational, Prospective) Study population: Patients with Pressure Ulcer who enter Tohoku University Hospital between Nov 1, 2015 and Oct 31, 2020, and meet all the inclusion criteria (Target sample size is 100).

Management information
Registered date	2015 Year 10 Month 16 Day
Last modified on	2017 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021530