Comparison of Patient Satisfaction Between 3 Types Dressing Shoes

This study is currently recruiting participants.
Verified August 2013 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: August 23, 2013
Last verified: August 2013
  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:


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 2014
Estimated Primary Completion Date: December 2013 (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 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: August 23, 2013
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on April 14, 2014