Heath-related Quality of Life of Diabetic Transmetatarsal... | NCT02445170

Studies
Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users

NCT02445170

Sponsor

Helsinki University Central Hospital

Status

Withdrawn

Last Update Posted

Aug 19, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Amputees
Diabetes Complications

Interventions

Amputation

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study is not eligible at present.

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

May 8, 2015

First Submission Date that Met QC Criteria

May 12, 2015

First Posted Date

May 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2016

Last Update Posted Date

Aug 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.

Detailed Description

The present study aims to recruit 100 diabetic transmetatarsal and below-knee prosthetic user to assess the health-related quality of life (HRQoL) between these two patient groups. The 15D HRQoL instrument is applied. An additional comparison with the age-standardized Finnish general population will be performed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Below-knee amputees		The present group consists of diabetic below-knee prosthetic user	Procedure: Amputation
Transmetatarsal amputees		The present group consists of diabetic transmetatarsal amputees	Procedure: Amputation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amputation	Procedure	Transmetatarsal or below-knee amputation	Below-knee amputees Transmetatarsal amputees

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health-related quality of life measured by the HRQoL score		2-5 years

Secondary Outcomes

Measure	Description	Time Frame
The 15D health-related quality of life instrument		2-5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with diabetes
Transmetatarsal amputation
Below-knee prosthetic user
2-5 years from surgery

Exclusion Criteria:

No diabetes
Other than transmetatarsal or below-knee amputation
Below-knee amputation but not a below-knee prosthetic user
Less than 2 years from the amputation
Over 5 years from amputation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diabetic patients who underwent transmetatarsal amputaion or below-knee prosthetic users in a time frame of 2-5 years from the amputation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erkki J Tukiainen, professor	Helsinki University Hospital and Helsinki University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki	Uusimaa	00029	Finland

Condition Browse Module

MeSH Terms

ID	Term
D048909	Diabetes Complications
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D004700	Endocrine System Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000671	Amputation, Surgical

Ancestor Terms

ID	Term
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided