Plain English Summary
Background and study aims
Verrucae (or plantar warts) are extremely common. They usually develop on the soles of the feet. They are flat and white in appearance and often have a black dot in the centre. They can be painful if they are on a weight-bearing part of the foot. They are caused by the human papilloma virus (HPV). Although most verrucae will spontaneously disappear without treatment, many patients seek treatment because they have persisted for many years, can be unsightly, can be painful or have prevented them from doing sports and other activities. There are many different treatments available, including the needling procedure. This involves using a fine needle to puncture the verrucae multiple times under a local anaesthesia. The goal is to place infected cells into the dermis (second layer of skin), to stimulate an immune response to destroy the virus. To date there has only been one small trial testing to see if this treatment works and no health economic analysis has been undertaken. In this study we will investigate the clinical and cost effectiveness of the Falknor needling procedure for the treatment of verrucae.
Who can participate?
Adults aged 18 or older with a verruca that is suitable for both scalpel debridement and dry needling.
What does the study involve?
Participants are randomly allocated into one of two groups. For those in group 1, their verruca is treated with scalpel debridement. For those in group 2, their verruca is treated using a needling procedure. All participants are then followed up for the next 24 weeks to see whether their verruca has been successfully removed or reduced in size, if they experienced any pain after treatment and whether they satisfied with the treatment offered.
What are the possible benefits and risks of participating?
It is anticipated that both the treatments will help by either reducing the size of the verruca or healing it completely. There may also be a reduction in pain associated with the verruca. However, this cannot be guaranteed. The information obtained from this study may help to inform treatment in the future for people with verrucae.
Where is the study run from?
Podiatry Division, School of Health and Social Care, University of Salford (UK)
When is the study starting and how long is it expected to run for?
March 2015 to November 2016
Who is funding the study?
University of Salford (UK)
Who is the main contact?
Dr Farina Hashmi
F.Hashmi@salford.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Farina Hashmi
ORCID ID
Contact details
School of Health Sciences
Centre for Health Sciences Research
Office: P.O. 41
Brian Blatchford building
Frederick Road Campus
University of Salford
Salford
Manchester
M6 6PU
United Kingdom
0161 295 5314
F.Hashmi@salford.ac.uk
Type
Scientific
Additional contact
Dr Sarah Cockayne
ORCID ID
Contact details
University of York
Department Health Sciences
York Trials Unit
ARRC Building Lower Ground Floor
York
YO10 5DD
United Kingdom
01904 321736
sarah.cockayne@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
EVerT2: dry needling versus nonsurgical debridement for the treatment of verrucae - a randomised controlled trial
Acronym
EVerT2
Study hypothesis
The null hypothesis is that there is no difference in the clearance rates of verrucae as assessed by a blinded independent assessor at 12 weeks post randomisation between the two treatment groups.
Ethics approval
1. University of Salford, College of Health and Social Care Research Ethics Committee, 25/02/2015, ref: HSCR15/24
2. University of York, Department of Health Sciences Research Governance Committee, 18/02/2015, ref: HSRGC/2014/98/B
Study design
This will be a pragmatic, open, two-armed randomised controlled trial conducted in one centre. Participants with verrucae will be randomised in a 1:1 ratio to receive the needling procedure or to callus debridement.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Plantar verrucae (or warts)
Intervention
1. Removal of callus over the plantar verruca and needling under local anaesthesia
2. Removal of callus over the plantar verruca without local anaesthesia
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
The participant’s verruca will be called the index verruca. In the case of a patient having multiple verrucae, the most painful or the largest verruca will be selected as the index verruca.
The primary outcome will be complete clearance of the index verruca at 12 weeks after randomisation as determined by blinded assessment by a HCPC registered podiatrist working at the clinical site. ‘Clearance’ of verruca will be defined as the restoration of normal skin upon close inspection, with the return of normal dermatoglyphics to the treated area of skin, i.e., uninterrupted skin striae as assessed by the podiatrist.
Secondary outcome measures
1. Clearance of the index verruca at 24 weeks as assessed in the same way as the primary outcome
2. Complete clearance of all verrucae at 12 and 24 weeks as assessed in the same way as the primary outcome
3. Self-reported clearance of all verrucae at 12 and 24 weeks
4. Self-reported time to clearance of all verrucae
5. Recurrence of verrucae at 24 weeks
6. Number of verrucae remaining at 12 and 24 weeks
7. Change in size of the ‘index’ verruca at 12 and 24 weeks (digital photographs of the verrucae will be taken for analysis using an appropriate software package to measure the surface area of the verruca(e))
8. Level of pain at 12 and 24 weeks
9. Level of pain 24 hours after the treatment
10. Number of treatments
11. Satisfaction with treatment at 12 and 24 weeks
Overall trial start date
25/03/2015
Overall trial end date
25/11/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Potential participants will be eligible if all of the following criteria apply:
1. The participant has a verruca that, in the opinion of the health care professional, is suitable for both treatments: scalpel debridement and dry needling
2. They are aged 18 years and over
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
58
Participant exclusion criteria
Potential participants will be excluded if any of the following criteria apply:
1. The participant, in the opinion of the health care professional, is not suitable for local anaesthesia
2. They are currently in a trial evaluating other treatments for their verruca
3. They have impaired healing e.g., due to diabetes, peripheral vascular disease or any other condition
4. They are immunosuppressed or are currently taking immunosuppressant drugs such as oral corticosteroids
5. They are unable or unwilling to give informed consent
6. They are currently on renal dialysis
7. They have peripheral neuropathy
8. The participant is pregnant
Recruitment start date
24/03/2015
Recruitment end date
01/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Podiatry Division, School of Health and Social Care, University of Salford
Salford
M6 6PU
Funders
Funder type
University/education
Funder name
University of Salford (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The main trial results and study protocol will form the basis of an academic paper in a peer reviewed journal on its completion.
The protocol will be published separately during the trial period in a peer reviewed academic paper.
The outcomes of the trial will be presented as a conference paper on completion of the trial.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26603251