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The non-surgical treatment of ingrown nails with a nail brace after removal of the nail part which pierces into the skin. A study in the foot clinic.

De niet chirurgische behandeling van een ingegroeide teennagel met een nagelbeugel nadat de nagelpunt welke in de huid prikt wordt verwijderd.



- candidate number25186
- NTR NumberNTR5979
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-aug-2016
- Secondary IDs16.08140 METC Isala
- Public TitleThe non-surgical treatment of ingrown nails with a nail brace after removal of the nail part which pierces into the skin. A study in the foot clinic.

De niet chirurgische behandeling van een ingegroeide teennagel met een nagelbeugel nadat de nagelpunt welke in de huid prikt wordt verwijderd.
- Scientific TitlePodiatric treatment of ingrown toenails with spiculectomy and orthonyxia in patients with and without risk factors for foot complications - a prospective observational study in a primary and secondary cohort.

De behandeling van ingegroeide teennagels middels spiculectomie en orthonyxie, uitgevoerd door een podotherapeut, bij patiënten met een hoog risico voor het ontwikkelen van voetproblemen. Een prospectieve observationele cohortstudie in de eerste- en tweedelijns podotherapie praktijk.
- ACRONYMOrthonyxia-1
- hypothesisIn this cohort study we aim to determine the safety and efficacy of treating ingrown nails with spiculectomy and orthonyxia in patients with and without risk factors for foot problems In deze studie willen we de veiligheid en effectiviteit beoordelen van de behandeling van een ingegroeide teennagel middels spiculectomie en orthonyxie uitgevoerd door een podotherapeut.
- Healt Condition(s) or Problem(s) studiedIngrown toenail, Diabetes Mellitus, Peripheral Arterial Disease
- Inclusion criteria1. Having an ingrown toenail
2. And aged ≥ 18 years

1 Het hebben van een ingegroeide teennagel
2 Een leeftijd > 18 jaar
- Exclusion criteria1. Patients with an allergy for chrome or nickel are excluded for orthonyxia, because the remanium wire is made of chrome/nickel stainless steel.
2. Patients with a toe pressure ≤ 15 mmHg are excluded from placing an orthonyxia because of the risk of pressure ulcers due to the poor skin condition. Spiculectomy will be performed in these patients.

1 Patienten met een allergie voor chroom/ nikkel worden geeëxcludeerd voor de orthonyxie aangezien een orthonyxie gemaakt wordt van remanium (chroom nikkel staal).
2 bij Patienten met een teendruk <15 mmHG wordt geen orthonyxie geplaatst aangezien de zeer matige kwaliteit van de huid mogelijk niet bestand is tegen de druk die het ijzerdraadje kan gaan geven. Spiculectomie zal wel uitgevoerd worden.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2016
- planned closingdate1-okt-2017
- Target number of participants100
- InterventionsSpiculectomy and orthonyxia are non-surgical interventions and are minimal invasive. During spiculectomy, the nail spicule that pierces the skin will be removed. After the nail spicule has been removed from the skin, the skin has to recover for 1-2 weeks. When the skin has been recovered the orthonyxia can be placed on the nail. Orthonyxia is a small brace of remanium wire (nickel / chrome stainless steel) with an omega shape on its highest level and u-shape hooks on both sides.
The brace will be placed, under tension, on the dorsum of the nail and will be fixated with gel. The wire guides regrowth resulting in decreased curvature of the nail.

Spiculectomie en orthonyxie zijn niet chirurgische, minimaal invasieve behandelingen. Bij spiculectomie word de punt van nagel die in de huid geprikt zit, verwijderd. Daarna zal de huid kunnen herstellen, waarna na 1-2 weken een bilaterale orthonyxie (nagelbeugel) onder spanning over de nagel wordt geplaatst om deze in haar uitgroei te begeleiden.
- Primary outcome• 26 week post-procedural complication rate (infection and hemorrhage)
• Pain during treatment (VAS)
• Pain reduction immediately after treatment
• Duration of pain (in days, VAS)
• Recurrence before 26 weeks
• Time to normal functioning / relief of symptoms
• Satisfying procedural result (VAS)
• Regrowth of the nail
• Need of analgetics
• Complete cure of the target nail at week 26 in patients with risk factors for foot problems
- Secondary outcome/
- Timepointspatients will be seen at baseline, 1-2 weeks after the first treatment, 12 weeks after the first treatment and there will be contact after 26 weeks
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES L. Nijenhuis
- CONTACT for SCIENTIFIC QUERIES L. Nijenhuis
- Sponsor/Initiator Isala Diabetes Centre, Innofeet Voetencentrum Nijenhuis
- Funding
(Source(s) of Monetary or Material Support)
Diabetes Fonds
- Publications
- Brief summaryRationale:
Ingrown toenails are a common problem in patients with and without comorbidity, but especially in patients with risk factors like diabetes or peripheral arterial disease. According to a Cochrane review, surgery seems to be to most effective treatment in preventing recurrence. In patients with diabetes or peripheral arterial disease the surgeon is reluctant to perform nail extractions due to the risk of complications. In clinical practise in the Isala hospital (Zwolle), spiculectomy and orthonyxia is often performed by a podiatrist as an alternative for the surgical treatment. During spiculectomy, the nail spicule that pierces the skin will be removed. Orthonyxia is a small brace of remanium wire which will be attached to the nailplate.

Objective:
In this cohort study we aim to determine the safety and efficacy of treating ingrown nails with spiculectomy and orthonyxia in patients with and without risk factors for foot problems.

Study design:
Prospective observational cohort study

Study population:
Primary and secondary care, adult patients with ingrown toenails.

Intervention:
Spiculectomy and orthonyxia performed by a podiatrist

Main study parameters/endpoints:
• Endpoints are complete cure of the target nail at week 26, 26 week post-procedural complication rate (infection and haemorrhage), pain during treatment (VAS), pain reduction immediately after treatment, duration of pain (in days, VAS), recurrence before 26 weeks, time to normal functioning / relief of symptoms, satisfying procedural result (VAS), regrowth of the nail, need of analgetics, complete cure of the target nail at week 26 in patients with risk factors for foot problems.
- Main changes (audit trail)
- RECORD18-aug-2016 - 7-sep-2016


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