Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05228340

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Amsterdam UMC - location MAMC

Amsterdam, North Holland, Netherlands, 1105AZ

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here