Skip to content

A study to compare two different pedal wart treatments.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000062729
Enrollment
30
Registered
2013-01-16
Start date
2012-06-01
Completion date
2012-08-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: The armamentarium for cutaneous warts is vast, the majority of which are not supported by high quality, randomised, controlled trials. We hypothesised that needling of a pedal wart would create local inflammation and a subsequent cell-mediated immune response against human papillomavirus. The primary objective of this study was to investigate if needling to induce cell-mediated immunity against human papillomavirus is an effective treatment of pedal warts in comparison to liquid nitrogen cryotherapy. A secondary objective of this study was to investigate if the cell-mediated immune response induced by needling is effective against satellite pedal warts. Methods: Eligible participants presenting to the University of Western Australia Podiatry Clinic with pedal wart/s were randomly allocated to treatment — either needling or nitrogen cryotherapy. Only the primary pedal wart was treated during the study. The participants were followed over a twelve-week period with outcome assessments made independently under blinded circumstances. Results: Thirty-seven participants were enrolled in the study with 18 allocated to needling and 19 to liquid nitrogen cryotherapy. Regression of the primary pedal wart occurred in 64.7% (11/17) of the needling group and 6.2% (1/16) of the liquid nitrogen cryotherapy group (p=0.001). There was no significant evidence to suggest needling of the primary pedal wart will result in regression of one or more satellite pedal warts (p=0.615) or complete pedal wart regression (p=0.175). There was no significant difference in pain, satisfaction or cosmesis between the two groups. Conclusions: The regression rate or the primary pedal wart is significantly higher in the needling group compared to the liquid nitrogen cryotherapy group. There is no significant evidence that needling of the primary pedal wart to induce a cell-mediated immune response is effective against satellite pedal warts.

Interventions

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

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.

Sponsors

Professor Reza Naraghi
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Eligible participants had one or more correctly diagnosed pedal cutaneous wart/s and were aged 18 years or over. A registered podiatrist confirmed diagnosis when the pedal wart exhibited both the characteristic pinpoint bleeding with debridement and pain on lateral compression.

Exclusion criteria

Participants were excluded from the study if they were prone to impaired healing (peripheral vascular disease, keloid scarring, anticoagulant therapy, haemophilia); were immunosuppressed or taking immunosuppressant drugs; were pregnant during the treatment period; had any previous adverse reactions to local anaesthetics; had suspected bacterial infection at the treatment site; were unable to give informed consent; were currently in a trial evaluating other treatments for their wart/s; were intending to treat their wart/s by other means during the trial period; had a primary pedal wart that was larger than 20mm in diameter; were receiving renal dialysis; had neuropathy; or were otherwise deemed not fit for treatment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026