The main objective 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, we aim to compare interphalangeal joints (IPJ) and metatarsal…
ID
Source
Brief title
Condition
- Diabetic complications
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ulcer recurrence of the toe, adjacent toe or metatarsal heads after one year of
follow-up.
Secondary outcome
Changes in distal interphalangeal joint, proximal interphalangeal joint and
metatarsophalangeal joint angles before and after flexor tenotomy in a
weight-bearing and non-weight-bearing position, barefoot pressure pattern
before and after flexor tenotomy, quality of life at inclusion and follow-up
and cost-effectiveness.
Background summary
Foot ulcers are a frequent problem in patients with diabetes mellitus and can
lead to amputations. Prevention of these ulcers is therefore of paramount
importance. Hammer/claw toe deformity is commonly seen in patients with
diabetes. These deformities increase the risk of ulcer development specifically
at the (tip of) the toe. Flexor tenotomy can be used to treat the consequences
of hammer toe deformity with the goal to prevent ulcer recurrence. For
indication and assessment of outcomes of flexor tenotomy, weight-bearing CT and
barefoot plantar pressure measurement can be used.
Study objective
The main objective 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, we aim to compare interphalangeal joints (IPJ)
and metatarsal phalangeal joint (MTPJ) angles in a weight-bearing and
non-weight-bearing position, bare-foot pressure and quality of life before and
after the intervention and between study groups.
Study design
A mono-center investigator blinded randomized controlled trial (RCT).
Intervention
A flexor tenotomy of toes with a claw or hammer toe deformity (intervention)
versus control group (standard of care including orthosis and shoe offloading).
Study burden and risks
The patients participating in this study will receive routine care, however
half of the subjects will receive a surgical treatment that in retrospective
cohorts has shown to reduce foot ulcer incidence. For research purposes,
additional weight-bearing and non-weight-bearing CT-scans will be obtained for
each patient. This project will yield a wealth of information on the
applicability and added value of flexor tenotomy. Results of the randomized
controlled trial will aid in decision-making while treating diabetic ulcers.
Results of functional image acquisition and analysis may facilitate treating
physicians in whether for example orthopedic surgery is indicated, if personal
modified soles need to be created and if the use of soles actually result in
the intended position changes of the foot.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
• Claw and/or hammer toe deformity
• A documented history of diabetic ulcers underneath the tip of the toe
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78504.018.21 |