BridgeMD
New treatment option for Hammer Toe Syndrome
Official title Flexor Tenotomy and Ulcer Recurrence
ClinicalTrials.gov ID: NCT05228340
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.