Foot Ulcer, Diabetic Clinical Trial
Official title:
The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC - location MAMC | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
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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