Foot Ulcer, Diabetic, Hammer Toe Syndrome
Conditions
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.
Detailed 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.
Interventions
PROCEDUREFlexor tenotomy
Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer recurrence | 24 months | Ulcer recurrence on the toe, adjacent toe, and metatarsal heads |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DIPJ, PIPJ and MTPJ angles | Baseline, 6 and 12 months | DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing |
| Barefoot pressure pattern | Baseline, 6 and 12 months | Barefoot pressure pattern |
| Patient-reported outcome measures: EuroQol's EQ-5D-5L | Baseline, 6, 12 and 24 months | Quality of life determined by EQ-5D-5L |
| Patient-reported outcome measures: SF-36 | Baseline, 6, 12 and 24 months | Quality of life determined by SF-36 |
| Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years | 24 months | Cost-effectiveness of additional flexor tenotomy compared to usual-care only |
Countries
Netherlands
Outcome results
None listed