Condition category
Surgery
Date applied
22/03/2005
Date assigned
14/04/2005
Last edited
07/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.action.org.uk/research_projects/grant/233/

Contact information

Type

Scientific

Primary contact

Dr Brendan McHugh

ORCID ID

Contact details

NCTEPO
University of Strathclyde
131 St James Rd
Glasgow
G4 0LS
United Kingdom
+44 (0)141 548 3692
b.mchugh@strath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AP0985

Study information

Scientific title

Acronym

Study hypothesis

Comparative evaluation of two types of prosthetic transtibial socket leading to better understanding of what constitutes a good socket design.

Ethics approval

Added 07/01/2010: Granted ethical approval by the Local Regional Health Authority and University Ethics Committees (ref EC/03/S/66)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Transtibial amputation

Intervention

Two groups of patients will each be randomly selected from among those amputees with one of the two socket types under assessment.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Measured pressure distribution, patient activity level and patients opinion elucidated by validated questionnaire for two socket concepts.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/04/2004

Overall trial end date

04/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Established amputees previously fitted with hand cast or pressure cast prosthetic sockets.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

05/04/2004

Recruitment end date

04/04/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NCTEPO
Glasgow
G4 0LS
United Kingdom

Sponsor information

Organisation

University of Strathclyde (UK)

Sponsor details

16 Richmond Street
Glasgow
G1 1XQ
United Kingdom

Sponsor type

University/education

Website

http://www.strath.ac.uk/

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19675992

Publication citations

  1. Results

    Dumbleton T, Buis AW, McFadyen A, McHugh BF, McKay G, Murray KD, Sexton S, Dynamic interface pressure distributions of two transtibial prosthetic socket concepts., J Rehabil Res Dev, 2009, 46, 3, 405-415.

Additional files

Editorial Notes