Flexor Tenotomy and Ulcer Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hammer Toe Syndrome Foot Ulcer, Diabetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

Flexor tenotomy

Group Type EXPERIMENTAL

Flexor tenotomy

Intervention Type PROCEDURE

Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon

Controle

Usual-care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Flexor tenotomy

Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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