RecruitingNot ApplicableNCT05228340

Flexor Tenotomy and Ulcer Recurrence

The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

66 participants

Start Date

Mar 15, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria11

  • 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
  • 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

Exclusion Criteria1

  • No written informed consent

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Interventions

PROCEDUREFlexor tenotomy

Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon


Locations(1)

Amsterdam UMC - location MAMC

Amsterdam, North Holland, Netherlands

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NCT05228340


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