Status:
RECRUITING
Flexor Tenotomy and Ulcer Recurrence
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Hammer Toe Syndrome
Foot Ulcer, Diabetic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main purpose of this study is to assess the efficacy of flexor tenotomy on the prevention of recurrence of toe ulcers in people with diabetes and a history of toe ulceration. Additionally, the inv...
Detailed Description
Foot ulcers are a frequent problem in patients with diabetes mellitus and can lead to amputations. Prevention of these ulcers is therefore of paramount importance. Claw/hammer toe deformity is commonl...
Eligibility Criteria
Inclusion
- 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
- A minimum of one claw/hammer toe
- A documented history of diabetic ulcers underneath the toe apex in the past 5 years
Exclusion
- 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
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05228340
Start Date
March 15 2022
End Date
February 1 2027
Last Update
March 29 2022
Active Locations (1)
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1
Amsterdam UMC - location MAMC
Amsterdam, North Holland, Netherlands, 1105AZ