The efficacy of flexor tenotomy on the prevention of recurrent diabetic foot ulcers: a randomized controlled trial
Recruiting
- Conditions
- diabetic soresDiabetic ulcers1001265310041297
- Registration Number
- NL-OMON50013
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 66
Inclusion Criteria
• A minimum age of 18 years
• Sufficient understanding of Dutch/English language
• Capable of filling out informed consent
• Peripheral polyneuropathy
• Diabetes mellitus type 1 or 2
• Claw and/or hammer toe deformity
• A documented history of diabetic ulcers underneath the tip of the toe
Exclusion Criteria
• No written informed consent
• Not meeting the inclusion criteria
• Open ulcers on the toes
• Previous participation in the study
• Pregnant women
• Concomitant participation in a study in which the patient is exposed to
X-rays
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Ulcer recurrence of the toe, adjacent toe or metatarsal heads after one year of<br /><br>follow-up. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Changes in distal interphalangeal joint, proximal interphalangeal joint and<br /><br>metatarsophalangeal joint angles before and after flexor tenotomy in a<br /><br>weight-bearing and non-weight-bearing position, barefoot pressure pattern<br /><br>before and after flexor tenotomy, quality of life at inclusion and follow-up<br /><br>and cost-effectiveness. </p><br>