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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05228340
Other study ID # NL78504.018.21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2022
Est. completion date February 2027

Study information

Verified date March 2022
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date February 2027
Est. primary completion date February 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Amsterdam UMC - location MAMC Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ulcer recurrence Ulcer recurrence on the toe, adjacent toe, and metatarsal heads 24 months
Secondary DIPJ, PIPJ and MTPJ angles DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing Baseline, 6 and 12 months
Secondary Barefoot pressure pattern Barefoot pressure pattern Baseline, 6 and 12 months
Secondary Patient-reported outcome measures: EuroQol's EQ-5D-5L Quality of life determined by EQ-5D-5L Baseline, 6, 12 and 24 months
Secondary Patient-reported outcome measures: SF-36 Quality of life determined by SF-36 Baseline, 6, 12 and 24 months
Secondary Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years Cost-effectiveness of additional flexor tenotomy compared to usual-care only 24 months
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