Condition category
Infections and Infestations
Date applied
10/03/2015
Date assigned
19/03/2015
Last edited
26/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

University of Salford

Sponsor details

School of Health Sciences
Centre for Health Sciences Research
Frederick Road Campus
University of Salford
Salford
Manchester
M6 6PU
United Kingdom

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes