EVerT2: dry needling versus nonsurgical debridement for the treatment of verrucae

ISRCTN	ISRCTN16429440
DOI	https://doi.org/10.1186/ISRCTN16429440
Protocol serial number	N/A
Sponsor	University of Salford
Funder	University of Salford Manchester

Submission date: 10/03/2015
Registration date: 19/03/2015
Last edited: 10/11/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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. The aim of this study is to 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

Contact information

Dr Farina Hashmi
Scientific

School of Health Sciences
Centre for Health Sciences Research
Office: PO 41, Brian Blatchford building
Frederick Road Campus
University of Salford
Salford
Manchester
M6 6PU
United Kingdom

Phone	+44 (0)161 295 5314
Email	F.Hashmi@salford.ac.uk

Dr Sarah Cockayne
Scientific

University of York
Department Health Sciences
York Trials Unit
ARRC Building Lower Ground Floor
York
YO10 5DD
United Kingdom

Phone	+44 (0)1904 321736
Email	sarah.cockayne@york.ac.uk

Study information

Primary study design	Interventional
Study design	Single-centre pragmatic open two-armed randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	EVerT2: dry needling versus nonsurgical debridement for the treatment of verrucae - a randomised controlled trial
Study acronym	EVerT2
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	Plantar verrucae (or warts)
Intervention	Participants with verrucae will be randomised in a 1:1 ratio to: 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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	25/11/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	58
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	24/03/2015
Date of final enrolment	01/12/2015

Locations

Countries of recruitment

United Kingdom

Study participating centre

University of Salford

Podiatry Division
School of Health and Social Care
Salford
M6 6PU

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2017		Yes	No
Protocol article	protocol	24/11/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/11/2017: Publication reference added.