Clinical trial NCT05228340: Flexor Tenotomy and Ulcer Recurrence
Official title: The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hammer Toe Syndrome
Foot Ulcer, Diabetic
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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. Claw/hammer toe deformity is commonly seen in patients with diabetes. These deformities increase the risk of ulcer development specifically at the (apex of) the toe. Tenotomy of the tendon of the flexor muscles of the toes (tendon tenotomy) can be used to treat the consequences of claw/hammer toe deformity with the goal to prevent ulcer recurrence. For indication and assessment of outcomes of flexor tenotomy, weight-bearing CT and dynamic barefoot plantar pressure measurement can be used. This mono-center investigator blinded randomized controlled trial will compare the flexor tenotomy with usual care (including orthoses and shoe offloading). The effect on ulcer recurrence, toe joint angles, barefoot plantar pressure and quality of life will be assessed and compared between the intervention and control group.

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

Primary outcomes:
measure: Ulcer recurrence
timeFrame: 24 months
Secondary outcomes:
measure: DIPJ, PIPJ and MTPJ angles
timeFrame: Baseline, 6 and 12 months
measure: Barefoot pressure pattern
timeFrame: Baseline, 6 and 12 months
measure: Patient-reported outcome measures: EuroQol's EQ-5D-5L
timeFrame: Baseline, 6, 12 and 24 months
measure: Patient-reported outcome measures: SF-36
timeFrame: Baseline, 6, 12 and 24 months
measure: Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years
timeFrame: 24 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - location MAMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam University Medical Centers
name: Gino M.M.J. Kerkhoffs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: