diabetic sores Diabetic ulcers
Conditions
Interventions
A flexor tenotomy of toes with a claw or hammer toe deformity (intervention)
versus control group (standard of care including orthosis and shoe offloading).
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 • Claw and/or hammer toe deformity • A documented history of diabetic ulcers underneath the tip of the toe
Exclusion criteria
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 |
|---|---|
| Ulcer recurrence of the toe, adjacent toe or metatarsal heads after one year of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in distal interphalangeal joint, proximal interphalangeal joint and metatarsophalangeal joint angles before and after flexor tenotomy in a weight-bearing and non-weight-bearing position, barefoot pressure pattern before and after flexor tenotomy, quality of life at inclusion and follow-up and cost-effectiveness. | — |
Countries
Netherlands
Outcome results
None listed