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Flexor Tenotomy and Ulcer Recurrence

RECRUITINGN/ASponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Actively Recruiting
PhaseN/A
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Started2022-03-15
Est. completion2027-02
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05228340

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 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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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
* A minimum of one claw/hammer toe
* A documented history of diabetic ulcers underneath the toe apex in the past 5 years

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

Conditions3

DiabetesFoot Ulcer, DiabeticHammer Toe Syndrome

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