Comparison of Patient Satisfaction Between 3 Types Dressing Shoes

This study is not yet open for participant recruitment.

Verified May 2012 by Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor:

Information provided by (Responsible Party):

Sheffield Teaching Hospitals NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01598714

First received: May 3, 2012

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

Purpose

This study compares patient satisfaction in terms of pain relief, mobility and ease of use between 3 commonly used types of post-surgical footwear. This study randomises patients who participate into one of 3 groups of footwear, namely Darco, Podalux or standard dressing shoe. Number of patients enrolled is determined by power calculation. Patients complete a single, simple previously validated questionnaire the MOXFQ (Manchester-Oxford Foot Questionnaire) at their 6 week follow-up appointment and statistical differences between the group are calculated using a significance level of p<0.05. This study will help us determine the best foot-wear to offer the investigators post-surgical patients.

This study will form original research.

Condition	Intervention
Patients Requiring Forefoot Surgery	Device: Darco shoe Device: Podalux shoe Device: Standard dressing shoe

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Comparison of Patient Satisfaction Between Darco, Podalux and Standard Dressing Shoes Following Forefoot Surgery

Resource links provided by NLM:

MedlinePlus related topics: Foot Health

U.S. FDA Resources

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:

Manchester-Oxford Foot Questionnaire (Outcome measure looking at foot pain,and function) [ Time Frame: Change from baseline at 6 weeks post-operative ] [ Designated as safety issue: No ]
Differences between the 2 groups in change from baseline in questionnaire score at 6 weeks post operative

Secondary Outcome Measures:

Surgical Shoe Questionnaire [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]
Questionnaire designed with questions regarding confort, and ease of use of post-operative surgical shoes

Estimated Enrollment:	90
Study Start Date:	July 2012
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Darco shoe Darco walking shoe provided	Device: Darco shoe Darco shoe
Podalux Shoe Podalus shoe	Device: Podalux shoe Podalux shoe
Standard dressing shoe Standard dressing shoe	Device: Standard dressing shoe Standard dressing shoe

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients over 18 years age
Patients normally independently mobile
Patients with no significant co-morbidities that would be expected to affect normal ambulation
Patients undergoing straightforward 1st ray surgery eg. 1st MTPJ arthrodesis, 1st metatarsal osteotomy, (in combination with 2nd ray procedures allowed)
Patients able to understand and complete questionnaires

Exclusion Criteria:

Patients under 18 years age
Patients not independently mobile
Patients with significant co-morbidities that effect normal ambulation (eg hip arthritis)
Patients undergoing complicated forefoot reconstructive surgery or surgery on rays other then 1st and 2nd.
Patients unable to understand or complete self-administered questionnaires

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598714

Contacts

Contact: Anna E Fox, MBChB	0114 2415980	anna.fox@sth.nhs.uk
Contact: Mark B Davies, MBChB		mark.davies@sth.nhs.uk

Locations

United Kingdom
Northern General Hospital	Not yet recruiting
Sheffield, S Yorks, United Kingdom, s5 7AU
Sub-Investigator: Anna E Fox, MBChB
Principal Investigator: Mark B Davies, MBChB
Sub-Investigator: Chris M Blundell, MBChB

Sponsors and Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

Study Director:	Mark B Davies, MBChB	Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator:	Chris M Blundell, MBChB	Sheffield Teaching Hosiptals NHS Trust

More Information

No publications provided

Responsible Party:	Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT01598714 History of Changes
Other Study ID Numbers:	STH15909
Study First Received:	May 3, 2012
Last Updated:	May 11, 2012
Health Authority:	United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on May 16, 2013

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