NCT02445170

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

May 8, 2015

Last Update Submit

August 17, 2016

Conditions

AmputeesDiabetes Complications

Keywords

Diabetesamputationbelow-kneetransmetatarsal[M01.150.100][C19.246.099]

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life measured by the HRQoL score

    2-5 years

Secondary Outcomes (1)

  • The 15D health-related quality of life instrument

    2-5 years

Study Arms (2)

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

AmputationPROCEDURE

Transmetatarsal or below-knee amputation

Below-knee amputeesTransmetatarsal amputees

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

MeSH Terms

Conditions

Diabetes ComplicationsDiabetes Mellitus

Interventions

Amputation, Surgical

Condition Hierarchy (Ancestors)

Endocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Erkki J Tukiainen, professor

    Helsinki University Hospital and Helsinki University

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 15, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

FI(1)