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Trial registered on ANZCTR

Registration number

ACTRN12613000062729

Ethics application status

Approved

Date submitted

15/01/2013

Date registered

16/01/2013

Date last updated

16/01/2013

Type of registration

Retrospectively registered

Titles & IDs

Public title

A study to compare two different pedal wart treatments.

Scientific title

A randomised controlled pilot study trial to compare the effectiveness of liquid nitrogen cryotherapy and needling in the treatment of pedal cutaneous warts within the population.

Secondary ID [1]

nil known

Universal Trial Number (UTN)

U1111-1138-5576

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

pedal warts

Condition category

Condition code

Skin

Other skin conditions

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The needling treatment involves breaking up the infected skin cells with a hypodermic needle.
This, in theory, creates an immune response which will kill the virus. This process is called cell mediated immunity.
We believe the Cell Mediated Immune Response, as a result of needling, to be created by 1) migration of immune cells to the local area due to an inflammatory response to injury, 2) manual lysing of infected epidermal cells to release the contained human papillomavirus (thereby exposing them to the immune cells), 3) translocating the virus in closer proximity to the papillary skin layer where there is a higher concentration of resident T-lymphocytes and, 4) sensitising the immune system to human papillomavirus antigen resulting in a CMIR against the human papillomavirus.

Needling treatment protocol
1. Local anaesthetic is administered; either local infiltration or block technique depending on the location and size of the wart.
2. Alcohol wipes are used as a disinfectant to clean the surface of the largest pedal wart and surrounding skin to be treated.
3. The wart is then debrided using a scalpel until pin-point bleeding is present.
4. Using a sterile 25-gauge needle the wart is punctured perpendicular to the surface through the spongy stroma and the base of the capsule into the subcutaneous fat.
5. This needling method is repeated, starting at the periphery and working circularly towards the centre of the wart until all of the papillae have been destroyed.
6. The wound is dressed with the Cutiplast. The Participant is supplied with adequate spare dressings.

Injectable Lignocaine or Lidocaine hydrochloride delivered by 25 gauge syringe.
Frequency: Prior to procedure, as required.
Maximum dose: 3mg/kg (up to 200mg) i.e 50kg adult may have 150mg of Lignocaine/Lidocaine.
Preparation: 1 or 2%

Typically in these procedures we would use up to 10ml of 1% lignocaine to achieve local anaesthesia.
In 10ml of 1% lignocaine preparation there is 100 mg of Lignocaine. The maximum recommended dose for a 50kg adult is 150mg.
This shows there is a large window between the doses to be delivered in this procedure and the maximum dose.
Uncommon adverse events associated with the use of local anesthetics include hypotension, bradycardia, arrhythmias, cardiac arrest, muscle twitching, seizures, coma and/or respiratory depression.

Australian Standard Infection Control policies will be in place to reduce any risk of bacterial or fungal infection, however, a certain degree of risk will always be present. Other possible complications such as bleeding, blistering, hindrances of daily activities, stress, and pain will be minimised.
- Bleeding will be controlled by an absorbent padded dressing applied under tension which will apply pressure to the wound and provide comfort for the patient.
- The wound will be monitored closely every two weeks for signs of infection and the Participant managed appropriately if such an event occurs.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control is liquid nitrogen cryotherapy, which is considered a first line, standard therapy for warts. Liquid Nitrogen cryotherapy involves destroying the infected cells through freezing. Freezing the infected tissue will kill the infected skin cells as well as the contained HPV.

Cryotherapy
1. Local anaesthetic is administered if necessary; either local infiltration or block technique depending on the location and size of the wart.
2. Alcohol is used as a disinfectant to clean the surface of the largest pedal wart and surrounding skin to be treated.
3. The wart is then debrided using a scalpel until pin-point bleeding is present.
4. Using a cotton wool swab and liquid nitrogen as the cryogen, the swab is applied to the entire surface of the wart until the lesion turns white (approximately 5-10 seconds).
5. The frozen tissue is then allowed to thaw for 30 seconds and the process is repeated once more.
6. Cutiplast is then applied over the wart. The Participant will be supplied with adequate spare dressings.

Injectable Lignocaine or Lidocaine hydrochloride delivered by 25 gauge syringe.
Frequency: Prior to procedure, as required.
Maximum dose: 3mg/kg (up to 200mg) i.e 50kg adult may have 150mg of Lignocaine/Lidocaine.
Preparation: 1 or 2%

Typically in these procedures we would use up to 10ml of 1% lignocaine to achieve local anaesthesia.
In 10ml of 1% lignocaine preparation there is 100 mg of Lignocaine. The maximum recommended dose for a 50kg adult is 150mg.
This shows there is a large window between the doses to be delivered in this procedure and the maximum dose.
Uncommon adverse events associated with the use of local anesthetics include hypotension, bradycardia, arrhythmias, cardiac arrest, muscle twitching, seizures, coma and/or respiratory depression.

Australian Standard Infection Control policies will be in place to reduce any risk of bacterial or fungal infection, however, a certain degree of risk will always be present. Other possible complications such as bleeding, blistering, hindrances of daily activities, stress, and pain will be minimised.
- Bleeding will be controlled by an absorbent padded dressing applied under tension which will apply pressure to the wound and provide comfort for the patient.
- Blistering after nitrogen cryotherapy treatment will be avoided by using a gentle freezing technique as apposed to an aggressive technique (we will only freeze the wart for approximately five seconds as apposed to an aggressive technique in which the wart would be frozen for thirty seconds). This will also aid in a quicker recovery for the patient.
- The wound will be monitored closely every two weeks for signs of infection and the Participant managed appropriately if such an event occurs.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome of this study was complete regression of the treated, primary wart at twelve weeks post initial treatment.

Regression was clinically defined as the return of normal skin striae.

High resolution, digital photographs were taken of the primary pedal wart at baseline and twelve weeks post initial treatment. A panel of two registered podiatrists, each with over 20 years experience, assessed the photographs. The panel members were blinded to the intervention and independently assessed whether the primary pedal wart had regressed. If the panel members’ outcomes conflicted, a third assessor was called upon to make the final decision.

Timepoint [1]