Post-amputation Survival Following Rehabilitation Medium... | NCT03539120

Studies
Post-amputation Survival Following Rehabilitation Medium and Long-term Follow up Study, a Retrospective Analysis.

NCT03539120

Sponsor

Changi General Hospital

Status

Completed

Last Update Posted

May 29, 2018Actual

Enrollment

73Actual

Phase

Not provided

Conditions

Amputation

Interventions

Follow up for survival

Countries

Not provided

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

Apr 2018

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

Mar 24, 2016Actual

Primary Completion Date

Jan 31, 2018Actual

Completion Date

Jan 31, 2018Actual

First Submitted Date

May 3, 2018

First Submission Date that Met QC Criteria

May 25, 2018

First Posted Date

May 29, 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

May 25, 2018

Last Update Posted Date

May 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up.

Investigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions.

Detailed Description

Inclusion criteria: Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.

Exclusion criteria: Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records.

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

73Actual

Name	Type	Description	Arm Group Labels	Other Names
Follow up for survival	Other	No intervention, this is an observational study of survival outcomes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival in relation to time	Survival outcomes were analysed and have been included in the results.	6 months to 6 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.

Exclusion criteria:

Exclusion Criteria:

Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

This study aimed to analyse survival outcome in patients with dysvascular lower limb amputation and identify relationship with existing comorbidities, i.e. diabetes mellitus (DM), peripheral vascular disease (PVD), ischaemic heart disease (IHD), estimated glomerular filtration rate (e-GFR), and chronic kidney disease (CKD). We also analysed the length of hospital stay, linear relationship with duration of DM, and vascular interventions.

Sampling Method

Non-Probability Sample

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