Flexor Tenotomy and Ulcer Recurrence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A minimum age of 18 years
Sufficient understanding of Dutch/English language
Capable of filling out informed consent
Peripheral polyneuropathy
Disqualifiers
No written informed consent
Not meeting the inclusion criteria
Open ulcers on the toes
Previous participation in the study
Trial design
Design model
Parallel
Treatments tested in this trial
Flexor tenotomy
Procedure/SurgeryMinimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControleNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Ulcer recurrence
Ulcer recurrence on the toe, adjacent toe, and metatarsal heads
Time frame
24 monthsSecondary outcomes
1
DIPJ, PIPJ and MTPJ angles
DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing
Time frame
Baseline, 6 and 12 months2
Barefoot pressure pattern
Barefoot pressure pattern
Time frame
Baseline, 6 and 12 months3
Patient-reported outcome measures: EuroQol's EQ-5D-5L
Quality of life determined by EQ-5D-5L
Time frame
Baseline, 6, 12 and 24 months4
Patient-reported outcome measures: SF-36
Quality of life determined by SF-36
Time frame
Baseline, 6, 12 and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov