Evidence map›Paper›PMID 36950303›Full record

ArticleContemporary clinical trials communications2023

The efficacy of flexor tenotomy to prevent recurrent diabetic foot ulcers (DIAFLEX trial): Study protocol for a randomized controlled trial.

M A Mens, T E Busch-Westbroek, S A Bus, J J van Netten, R H H Wellenberg, G J Streekstra, M Maas, M Nieuwdorp, G M M J Kerkhoffs, S A S Stufkens

Registry-linked trialOpen access · goldFull text read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05228340 (The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05228340 narecruitingnot on this map

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

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2022 to 2027Enrolled66ConditionsHammer Toe Syndrome, Foot Ulcer, DiabeticArmsFlexor tenotomy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Observational
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

M A MensAmsterdam UMC, Location University of Amsterdam, Radiology and Nuclear Medicine, Meibergdreef 9, Amsterdam, the Netherlands.
T E Busch-WestbroekAmsterdam UMC, Location University of Amsterdam, Rehabilitation Medicine, Meibergdreef 9, Amsterdam, the Netherlands.
S A BusAmsterdam UMC, Location University of Amsterdam, Rehabilitation Medicine, Meibergdreef 9, Amsterdam, the Netherlands.
J J van NettenAmsterdam UMC, Location University of Amsterdam, Rehabilitation Medicine, Meibergdreef 9, Amsterdam, the Netherlands.
R H H WellenbergAmsterdam UMC, Location University of Amsterdam, Radiology and Nuclear Medicine, Meibergdreef 9, Amsterdam, the Netherlands.
G J StreekstraAmsterdam UMC, Location University of Amsterdam, Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, the Netherlands.
M MaasAmsterdam UMC, Location University of Amsterdam, Radiology and Nuclear Medicine, Meibergdreef 9, Amsterdam, the Netherlands.
M NieuwdorpAmsterdam UMC, Location University of Amsterdam, Internal Medicine, Meibergdreef 9, Amsterdam, the Netherlands.
G M M J KerkhoffsAmsterdam UMC, Location University of Amsterdam, Orthopaedic Surgery, Meibergdreef 9, Amsterdam, the Netherlands.
S A S StufkensAmsterdam UMC, Location University of Amsterdam, Orthopaedic Surgery, Meibergdreef 9, Amsterdam, the Netherlands.
Amsterdam University Medical Centers · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Foot ulcers are a frequent and costly problem in people with diabetes mellitus and can lead to amputations. Prevention of these ulcers is therefore of paramount importance. Claw/hammer toe deformities are commonly seen in people with diabetes. These deformities increase the risk of ulcer development specifically at the (tip of) the toe. Percutaneous needle tenotomy of the tendon of the m. flexor digitorum longus (tendon tenotomy) can be used to reduce the severity of claw/hammer toe deformity with the goal to prevent ulcer recurrence. The main objective of this randomized controlled trial is to assess the efficacy of flexor tenotomy to prevent recurrence of toe ulcers in people with diabetes and a history of toe (pre-)ulcers. Additionally, we aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, barefoot plantar pressure during walking, cost-effectiveness and quality of life before and after the intervention and compare intervention and control study groups. Sixty-six subjects with diabetes and claw/hammer toe deformity and a recent history of (pre-)ulceration on the tip of the toe will be included and randomized between flexor tenotomy of claw/hammer toes (intervention) versus standard of care including orthosis and shoe offloading (controls) in a mono-center randomized controlled trial. Clinicaltrialsgov registration: NCT05228340.

Indexed as

CBCT, Cone-Beam Computed TomographyDIPJ, Distal Interphalangeal JointDM, Diabetes MellitusFlexor tenotomyFoot ulcerIPJ, Interphalangeal JointMTPJ, Metatarsal Phalangeal JointPIPJ, Proximal Interphalangeal JointPreventionRCT, Randomized Controlled TrialROI, Region Of InterestSD, Standard DeviationSF-36, Short-Form-36Toe deformityWTBCT, Weight-Bearing CTμSv, Microsievert

Identifiers

PMID36950303
PMCPMC10027496
OpenAlexW4323816843

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read10
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.