Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
19/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ian Robinson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0620171683

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Single-centre blinded randomised comparative trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Phenol

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2005

Overall trial end date

06/10/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2 groups of 30

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

06/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Podiatry
Exeter
EX1 1PQ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Exeter Primary Care Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes