The long-term effectiveness of 40% salicylic acid plasters on corns
| ISRCTN | ISRCTN13166839 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13166839 |
| Secondary identifying numbers | Protocol Version 3 - December 2008 |
- Submission date
- 09/12/2008
- Registration date
- 16/01/2009
- Last edited
- 16/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Wesley Vernon
Scientific
Scientific
Podiatry Services
Jordanthorpe Health Centre
1 Dyche Close
Sheffield
S8 8DJ
United Kingdom
| Phone | +44 (0)114 2371183 |
|---|---|
| wesley.vernon@sheffieldpct.nhs.uk |
Study information
| Study design | Prospective pragmatic parallel-group randomised controlled trial with equal randomisation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The long-term effectiveness of 40% salicylic acid plasters on corns: a prospective pragmatic parallel-group randomised controlled trial |
| Study hypothesis | Null hypothesis: there is no difference in clinical and patient-centred outcomes in treatment of corns between use of corn plasters and usual treatment. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Corns occuring on the foot |
| Intervention | 308 participants will be recruited, 154 in each arm. One arm will receive 40% salicylic acid corn plaster treatment, the other usual 'scalpel' treatment. All study participants will be asked to describe the amount of pain experienced from the lesion at each visit using a visual analogue scale (VAS), whether they are satisfied with the treatment they are receiving using a simple questionnaire with pre-coded responses, to complete the Foot Disability Questionnaire and the Euro Quality of Life (EQ5D) instrument. These will be completed at each 3-monthly appointment and administered by the independent podiatrist (rater). Patients in the corn plaster arm will then have the area cleared and a plaster applied and advised to keep on until the next visit 5 - 7 days later. On return, the plaster is removed and if the corn is loose, removal can be facilitated with blunt dissection. The plaster will be re-applied if the corn is still present and reviewed weekly for up to 4 weeks from initial treatment, with a plaster applied at each visit if the corn is still present. The size of the corn (if still present) will be documented at 3-monthly intervals for up to 12 months after initial treatment by an independent podiatrist blind to the initial treatment allocation. If the corn has resolved, this will be checked at each visit and documented. Patients in the scalpel treatment arm will have the corn removed with a scalpel at the initial treatment and then reviewed at 3-monthly intervals for 12 months where the size of the corn with be recorded if still present, with removal of the corn carried out at each appointment if required. Any dissatisfaction with either treatment or complications will be recorded at each visit. In the event of an adverse reaction (development of infection, or unbearable pain), subjects will be provided with the appropriate podiatry care to alleviate symptoms but follow-up data will still be collected unless the participant withdraws their consent. Anyone in the corn plaster group whose corn re-occurs after initial monthly corn plaster treatment will receive usual scalpel treatment at 3-monthly intervals and this data will be included in the analysis under the intention to treat principle. Participating podiatrists will be asked to complete a short questionnaire to assess their view of the two treatments at the end of the study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Salicylic acid |
| Primary outcome measure | Presence at 3 months post-randomisation of an unhealed or recurrent corn that requires further ongoing treatment. |
| Secondary outcome measures | 1. Presence of unhealed or recurrent corns at 12 months 2. Mean Visual Analogue Scale (VAS) pain score at 3, 6, 9 and 12 months 3. Foot pain disability scores at 3, 6, 9 and 12 months 4. Cost-effectiveness of corn plaster compared with usual care 5. Podiatrist satisfaction with the two treatments at 12 months 6. Patient satisfaction at 3, 6, 9 and 12 months |
| Overall study start date | 01/04/2009 |
| Overall study end date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 308 |
| Participant inclusion criteria | 1. Adult patients (male and female subjects aged 18 years and older) with corns 2. Patients who are willing to take part for the duration of the study 3. Patients who have the capacity to make an informed decision and give informed consent |
| Participant exclusion criteria | 1. Diabetes 2. Impaired circulation (including peripheral vascular disease, ischaemia) 3. A history of foot ulceration 4. Rheumatoid arthritis 5. Taking oral steroid medication 6. Dermatological conditions 7. Allergies to zinc oxide plaster 8. Allergies to salicylic acid 9. Neuropathy 10. Completely unable to reach their feet 11. Callus only and no corns 12. Infected corns or neurovascular corns 13. Pregnant or breast feeding 14. Peanut or soya allergy |
| Recruitment start date | 01/04/2009 |
| Recruitment end date | 31/03/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Jordanthorpe Health Centre
Sheffield
S8 8DJ
United Kingdom
S8 8DJ
United Kingdom
Sponsor information
Sheffield Health and Social Research Consortium (UK)
Government
Government
c/o Dr Robert Dixon
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom
| Phone | +44 (0)114 2718804 |
|---|---|
| robert.dixon@shsc.nhs.uk | |
| Website | http://www.shsrc.nhs.uk/ |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: 2008-005313-21)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/09/2013 | Yes | No | |
| Results article | results | 08/12/2015 | Yes | No |
