HRQoL Among Patients Amputated Due to Peripheral Arterial... | NCT03570788

Studies
HRQoL Among Patients Amputated Due to Peripheral Arterial Disease

NCT03570788

Sponsor

Jonas Malmstedt

Status

Completed

Last Update Posted

Jun 28, 2019Actual

Enrollment

98Actual

Phase

Not provided

Conditions

Quality of Life
Amputation
Peripheral Arterial Disease
Prosthesis User

Interventions

Amputation

Countries

Sweden

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

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2014Actual

Primary Completion Date

May 20, 2019Actual

Completion Date

May 20, 2019Actual

First Submitted Date

Jun 13, 2018

First Submission Date that Met QC Criteria

Jun 25, 2018

First Posted Date

Jun 27, 2018Actual

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

Jun 27, 2019

Last Update Posted Date

Jun 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.

Detailed Description

Not provided

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

98Actual

Name	Type	Description	Arm Group Labels	Other Names
Amputation	Procedure	Major amputation defined as at or above ankle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Health related quality of life according to EQ-5D	The change in HRQoL between baseline and after 1 year. Measured with EQ-5D-3L	1 year

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients using prosthesis	Prosthesis use after a major amputation is measured with Stanmore mobility grade	1 year after the amputation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients amputated at femoral, knee or tibial level due to peripheral arterial disease

Exclusion Criteria:

Patients not able to provide informed consent
Patients not able to verbally express their experience of the amputation.
Patients that not speak Swedish

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

All patients amputated at Södersjukhuset during 2014-2018 are reviewed based on criteria for inclusion and exclusion. All patients that meets the inclusion criteria during the period will be contacted by the researcher in connection with the amputation and informed about the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Torbjörnsson	Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet		Stockholm		SE-118 83	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular 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