Radio surgery versus 80% phenol for toe nail matrix ablation: a randomised comparison study
| ISRCTN | ISRCTN32883274 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32883274 |
| Secondary identifying numbers | N0620171683 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 19/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Mr Ian Robinson
Scientific
Scientific
Podiatry
Dean Clarke House
Southernhay East
Exeter
EX1 1PQ
United Kingdom
Study information
| Study design | Single-centre blinded randomised comparative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Phenol |
| Primary outcome measure | 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 study start date | 01/09/2005 |
| Completion date | 06/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 2 groups of 30 |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Podiatry
Exeter
EX1 1PQ
United Kingdom
EX1 1PQ
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Exeter Primary Care Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
