Preventing toe ulcers in diabetic patients through flexor tenotomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of flexor tenotomy in preventing the recurrence of toe ulcers in diabetic patients with a history of toe ulceration. It aims to assess changes in interphalangeal and metatarsophalangeal joint angles, barefoot plantar pressure during walking, and quality of life before and after the intervention. The study is a mono-center, investigator-blinded, randomized controlled trial comparing flexor tenotomy to usual care, which includes orthoses and shoe offloading. Outcomes will be measured and compared between the intervention and control groups to determine the efficacy of the treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Amsterdam UMC - location MAMC
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Gino M.M.J. Kerkhoffs, MD, PhD — Amsterdam UMC, location VUmc

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.