Flexor Tenotomy and Ulcer Recurrence

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jan 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called flexor tenotomy to see if it can help prevent toe ulcers from coming back in people with diabetes who have had toe ulcers before. The researchers want to find out how this procedure affects the angles of certain toe joints and how much pressure is put on the foot while walking. They will also look at how the treatment might improve the participants' quality of life.

To join the study, participants need to be at least 18 years old, speak Dutch or English well enough to understand the details, and have a history of toe problems related to diabetes, including at least one claw or hammer toe and previous toe ulcers. Participants can expect to undergo evaluations before and after the treatment, which will help researchers determine if the flexor tenotomy is effective. It's important to note that people with open ulcers on their toes, pregnant women, or those currently involved in other studies may not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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