Comparison of Patient Satisfaction Between 3 Types Dressing Shoes

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014