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Recruiting NCT05228340

Flexor Tenotomy and Ulcer Recurrence

No phase Interventional Hammer Toe Syndrome Foot Ulcer, Diabetic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Flexor tenotomy.
Who it may be relevant to
Registry conditions: Hammer Toe Syndrome, Foot Ulcer, Diabetic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial

Overview

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.

Interventions

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

Primary outcome measures

  • Ulcer recurrence [Time frame: 24 months]
Secondary outcome measures (5)
  • DIPJ, PIPJ and MTPJ angles [Time frame: Baseline, 6 and 12 months]
  • Barefoot pressure pattern [Time frame: Baseline, 6 and 12 months]
  • Patient-reported outcome measures: EuroQol's EQ-5D-5L [Time frame: Baseline, 6, 12 and 24 months]
  • Patient-reported outcome measures: SF-36 [Time frame: Baseline, 6, 12 and 24 months]
  • Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years [Time frame: 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Netherlands · 1 center
  • Amsterdam UMC - location MAMC — Amsterdam

Publications

  • Mens MA, Busch-Westbroek TE, Bus SA, van Netten JJ, Wellenberg RHH, Streekstra GJ, Maas M, Nieuwdorp M, Kerkhoffs GMMJ, Stufkens SAS. The efficacy of flexor tenotomy to prevent recurrent diabetic foot ulcers (DIAFLEX trial): Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2023 Mar 11;33:101107. doi: 10.1016/j.conctc.2023.101107. eCollection 2023 Jun. PMID 36950303

Identifiers

NCT: NCT05228340 · NL78504.018.21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗