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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
66
Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon
Amsterdam UMC - location MAMC
Amsterdam, North Holland, Netherlands
RECRUITINGUlcer recurrence
Ulcer recurrence on the toe, adjacent toe, and metatarsal heads
Time frame: 24 months
DIPJ, PIPJ and MTPJ angles
DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing
Time frame: Baseline, 6 and 12 months
Barefoot pressure pattern
Barefoot pressure pattern
Time frame: Baseline, 6 and 12 months
Patient-reported outcome measures: EuroQol's EQ-5D-5L
Quality of life determined by EQ-5D-5L
Time frame: Baseline, 6, 12 and 24 months
Patient-reported outcome measures: SF-36
Quality of life determined by SF-36
Time frame: Baseline, 6, 12 and 24 months
Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years
Cost-effectiveness of additional flexor tenotomy compared to usual-care only
Time frame: 24 months
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