Comparison of Patient Satisfaction Between 3 Types Dressing Shoes (NCT01598714) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Patient Satisfaction Between 3 Types Dressing Shoes
United Kingdom83 participantsStarted 2012-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Manchester-Oxford Foot Questionnaire (Outcome measure looking at foot pain,and function)
Timeframe: Change from baseline at 6 weeks post-operative
Trial details
NCT IDNCT01598714
SponsorSheffield Teaching Hospitals NHS Foundation Trust