The evaluation of three treatments for plantar callus : a three armed randomised,
comparative trial using biophysical outcome measures

Hashmi, F; Nester, CJ; Wright, CRF; Lam, S

Abstract

Callus is one of the most common foot skin complaints experienced by people of all
ages. These painful and unsightly lesions often result in disability. The gold standard of
treatment is scalpel debridement by a trained specialist; however people also seek
over the counter remedies. There is a lack of clinical evidence for the efficacy of such
products, which makes the selection by patients and practitioners difficult.
Method:
This randomised, three armed, parallel, comparative trial aimed to test the efficacy of
two home treatments for plantar callus using novel, objective outcome measures (skin
hydration using the capacitance method; elasticity using the negative pressure
application and surface texture using imaging). Additional outcome measures were:
size of callus, quality of life (Foot Health Status Questionnaire) and self-reported
participant satisfaction and compliance. The results were compared to a podiatry
treatment. Participants were randomly allocated to one of three groups: potassium
hydroxide (KOH, 40%); trichloroacetic acid (TCA) and podiatry treatment. Participants
were followed for three weeks after their initial intervention appointment (day 7, 14 and
21). The primary outcomes were the change from baseline in callus hydration,
elasticity, texture and size at each of the three time points. The secondary outcomes
where: change in quality of life 21 days after treatment; resolution of calluses via visual
inspection and participant compliance and perception.
Results:
Forty six participants (61 feet) with plantar calluses were recruited. The podiatry
treatment showed immediate and significant changes in all objective outcomes;
associated foot pain and function (p < 0.01). Lesser changes in skin quality and
perceived pain and function benefits occurred with TCA and KOH over 21 days.
Conclusions:
This is the first study where objective outcome measures have been used to measure
changes in the nature of skin in response to callus treatments. We found significant
differences in plantar callus in response to podiatry and two home treatments. The
podiatry treatment showed immediate and significant changes in skin and associated
foot pain and function. Lesser, but sometimes comparable, changes in skin and
perceived pain and function benefits occurred with TCA and KOH over 21 days.
Trial registration: ISRCTN 14751843

Citation

comparative trial using biophysical outcome measures. Trials, 17(251), https://doi.org/10.1186/s13063-016-1377-2

• Journal Article Type: Article
• Acceptance Date: Apr 29, 2016
• Online Publication Date: May 17, 2016
• Publication Date: May 17, 2016
• Deposit Date: May 6, 2016
• Publicly Available Date: May 6, 2016
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Volume: 17
• Issue: 251
• DOI: https://doi.org/10.1186/s13063-016-1377-2
• Publisher URL: http://dx.doi.org/10.1186/s13063-016-1377-2