Actively Recruiting
Flexor Tenotomy and Ulcer Recurrence
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2022-03-29
66
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 investigators aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, bare-foot plantar pressure during walking and quality of life before and after the intervention and compare between study groups.
CONDITIONS
Official Title
Flexor Tenotomy and Ulcer Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A minimum age of 18 years
- Sufficient understanding of Dutch or English language
- Able to give informed consent
- Presence of peripheral polyneuropathy
- Diagnosis of diabetes mellitus type 1 or 2
- At least one claw or hammer toe
- History of diabetic ulcers under the toe tip within the past 5 years
You will not qualify if you...
- No written informed consent
- Does not meet inclusion criteria
- Open ulcers on the toes
- Previous participation in this study
- Pregnant women
- Participating in another study involving X-rays
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC - location MAMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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