| NCT ID | NCT05228340 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Hammer Toe Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2022-03-15 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2022-03-15 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Gino M.M.J. Kerkhoffs, MD, PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location VUmc
Frequently Asked Questions
Who can join the NCT05228340 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hammer Toe Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05228340 currently recruiting?
Yes, NCT05228340 is actively recruiting participants. Visit ClinicalTrials.gov or contact Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) to inquire about joining.
Where is the NCT05228340 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05228340 clinical trial?
NCT05228340 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Gino M.M.J. Kerkhoffs, MD, PhD at Amsterdam UMC, location VUmc. The trial plans to enroll 66 participants.