Radio surgery versus 80% phenol for toe nail matrix ablation: a randomised comparison study

ISRCTN	ISRCTN32883274
DOI	https://doi.org/10.1186/ISRCTN32883274
Protocol serial number	N0620171683
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Exeter Primary Care Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Ian Robinson
Scientific

Podiatry
Dean Clarke House
Southernhay East
Exeter
EX1 1PQ
United Kingdom

Primary study design	Interventional
Study design	Single-centre blinded randomised comparative trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Radio surgery versus 80% phenol for toe nail matrix ablation: a randomised comparison study
Study objectives	Does the wound heal faster when 80% phenol is used to destroy the nail-producing cells or is healing faster when radio surgery is used to destroy the nail-producing cells?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Toenail matrix ablation
Intervention	60 participants (patients who have been referred for nail surgery) will be allocated an ID number. 30 randomised to 80% phenol and 30 will receive radio surgery technique for nail matrix ablation using a random number code.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Phenol
Primary outcome measure(s)	Healing time of the wound (to the nearest week). Pain experienced at each return visit following surgery measured using a visual scale, post-operative infection incidence measured by clinical signs and symptoms, nail regrowth incidence measured by clinical signs and symptoms, time to nail regrowth following surgery.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	06/10/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Subjects will be males and females 2. Aged 18-80 years 3. They will be individuals referred to the podiatry department at the Royal Devon and Exeter Hospital (Heavitree) for nail surgery under local anaesthesia 4. They will present with a condition indicating the need for nail surgery including the following conditions: 4.1 Ingrowing toenail 4.2 Involuted nail 4.3 Fungal infection of the nail 4.4 Thickening of the nail 4.5 Severe nail hypertrophy 5. Each subject must be able to attend for follow-up visits including a 6-month visit and be able to provide informed consent 6. Participants will be happy to have their toe photographed and will be happy to be contacted by telephone after 1 year
Key exclusion criteria	1. Fitted with a pacemaker, artificial heart valve, artificial joints or any other type of implant because these are contra-indications to radiosurgery 2. Subungual exostosis because treatment other than nail surgery is required for this condition 3. Contraindication to anaesthesia or the procedure according to standard guidelines 4. Pregnancy or breastfeeding 5. Unable to give informed consent 6. Inadequate blood supply to the foot or toe
Date of first enrolment	01/09/2005
Date of final enrolment	06/10/2007

Podiatry

Exeter
EX1 1PQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes