Amsterdam UMC - location MAMC
Amsterdam, North Holland, 1105AZ, Netherlands
Location status: Recruiting
Location contact
Gino M.M.J. Kerkhoffs, Professor
PRINCIPAL_INVESTIGATOR
Mens
CONTACT
NCT Number: NCT05228340
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amsterdam, North Holland, 1105AZ, Netherlands
Location status: Recruiting
Gino M.M.J. Kerkhoffs, Professor
PRINCIPAL_INVESTIGATOR
Mens
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon
Time frame: 24 months
Ulcer recurrence on the toe, adjacent toe, and metatarsal heads
Time frame: Baseline, 6 and 12 months
DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing
Time frame: Baseline, 6 and 12 months
Barefoot pressure pattern
Time frame: Baseline, 6, 12 and 24 months
Quality of life determined by EQ-5D-5L
Time frame: Baseline, 6, 12 and 24 months
Quality of life determined by SF-36
Time frame: 24 months
Cost-effectiveness of additional flexor tenotomy compared to usual-care only
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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