NCT05228340

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2022Feb 2027

First Submitted

Initial submission to the registry

January 11, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

4.9 years

First QC Date

January 11, 2022

Last Update Submit

March 15, 2022

Conditions

Hammer Toe SyndromeFoot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

  • Ulcer recurrence

    Ulcer recurrence on the toe, adjacent toe, and metatarsal heads

    24 months

Secondary Outcomes (5)

  • DIPJ, PIPJ and MTPJ angles

    Baseline, 6 and 12 months

  • Barefoot pressure pattern

    Baseline, 6 and 12 months

  • Patient-reported outcome measures: EuroQol's EQ-5D-5L

    Baseline, 6, 12 and 24 months

  • Patient-reported outcome measures: SF-36

    Baseline, 6, 12 and 24 months

  • Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years

    24 months

Study Arms (2)

Intervention

EXPERIMENTAL

Flexor tenotomy

Procedure: Flexor tenotomy

Controle

NO INTERVENTION

Usual-care

Interventions

Flexor tenotomyPROCEDURE

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No written informed consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC - location MAMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Publications (1)

  • 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: 36950303DERIVED

MeSH Terms

Conditions

Hammer Toe SyndromeDiabetic Foot

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Gino M.M.J. Kerkhoffs, MD, PhD

    Amsterdam University Medical Centers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coördinating investigator

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 8, 2022

Study Start

March 15, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)