The long term effectiveness of 40% salicylic acid plasters on corns

Phase 1

• Conditions: Corns; MedDRA version: 9.1 Level: LLT Classification code 10011064 Term: Corns

• Registration Number: EUCTR2008-005313-21-GB
• Lead Sponsor: Sheffield Health and Social Research Consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-16
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 308

Inclusion Criteria

Adult patients with corns, patients who are willing to take part for the duration of the study and patients who have the capability to make an informed decision and give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with: diabetes, impaired lower limb circulation, a history of foot ulceration, rheumatoid arthrtitis, taking oral steriod medication, who have dermatological conditions, who are allergic to Zinc Oxide plaster, allertgic to salicylic acid, patient with neuropathy, patients unable to reach their feet, patients with callus and no corns, patients with infected or neurovascular corns, patients who are pregnant or breast feeding, patients with a peanut or soya allergy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long term effectiveness of 40% salicylic acid plasters on corns when compared with 'usual' treatment which is scalpel debridement in terms of the proportion of unhealed or recurrent corns remaining over a 12-month period.;Secondary Objective: To evaluate the cost-effectiveness of corn plasters compared with scalpel corn removal, to compare patient centred outcomes in terms of pain, foot disability and quality of life and satisfaction. To explore podiatrists' views of the two treatments.;Primary end point(s): Presence at 3 months post randomisation of an unhealed or recurrent corn that requires further ongoing treatment.