Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000591651
Ethics application status
Approved
Date submitted
25/05/2014
Date registered
4/06/2014
Date last updated
28/06/2021
Date data sharing statement initially provided
28/06/2021
Date results information initially provided
28/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of mechanical debridement with scalpel for plantar callosities
Scientific title
The effect of mechanical debridement in patients suffering from plantar callosities on pain and disability
Secondary ID [1] 284634 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EMEDESCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
plantar callosities on foot 291949 0
Condition category
Condition code
Skin 292299 292299 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention A: The podiatrist performing the intervention A removes keratin layers of the callus by mechanical debridement with a scalpel blade number 15, seen yellow and hard consistency, until the skin is softer and pink. The procedure is performed in a single session and does not require anesthesia. And subsequent protection with felt or padding if necesary.
Intervention B: Aplication of keratolytic (salicylic acid) as a patch 3 days without wetting. Cut a piece of patch the size of the lesion to be removed. Apply the dressing over the affected part clean and dry, covering it with a patch. Leave it until the corns or callosities can be removed painlessly using a hot water bath (3 days). The participants remove the patch themselves. The calluses remove by the keratolytic action of salicylic acid. The concentration of salicylic acid is 35 percent.
Intervention code [1] 289419 0
Treatment: Surgery
Intervention code [2] 289420 0
Treatment: Drugs
Comparator / control treatment
Standard treatment: application of keratolytic (salicylic acid) patch. Is the same as intervention B.
Control group
Active

Outcomes
Primary outcome [1] 292167 0
The Visual Analogue Scale pain (VAS) is a continuous quantitative variable. This is measurements have been traditionally used for measuring foot pain. It consists of a line of 10 centimeter divided into 10 sections of 0-10 where 0 is no pain and 10 is the maximum tolerable pain
Timepoint [1] 292167 0
baseline, inmediately after the intervention, 15 and 45 days after
Primary outcome [2] 292168 0
The Manchester Foot Pain and Disability Index (MFPDI) is a self-assessment 19-item questionnaire developed in the UK to measure foot pain and disability.The remaining 17 items constitute three constructs (sub-scales): functional limitation (10 items), pain intensity (5 items) and concern with personal appearance (2 items). Each of the 17 statements has a 3-category response structure: ‘none of the time’ = 0, ‘on some days’ = 1 and ‘on most/every day(s)’ = 2. The MFPDI has been validated in middle-aged and older populations and has been used as an outcome measure both in large population- based surveys and in clinical studies, including randomised controlled trials. The MFPDI has also been used in studies of various diseases with foot manifestations including systemic sclerosis, Ehlers–Danlos syndrome and rheumatoid arthritis.
Timepoint [2] 292168 0
Baseline, 15 and 45 days after intervention
Primary outcome [3] 292169 0
The short form Health Survey (SF-12) is a general health questionnaire.The 12 questions that comprise measured eight dimensions (variables) of quality of life related to health and two abstract components, obtained by applying an algorithm that transforms scores typifies subjects and making them directly comparables
1) Physical Function (PF) 2) Physical role (PR) 3) bodily pain (BP) 4) General Health (GH) 5) Vitality (VT): 6) social functioning (SF): 7) Role emotional (RE) 8) Mental Health (MH)

Timepoint [3] 292169 0
Baseline and 45 days after the intervention
Secondary outcome [1] 308355 0
Nil
Timepoint [1] 308355 0
Nil

Eligibility
Key inclusion criteria
Patients with plantar callosities or corns on forefoot area, with one or more of pain in forefoot area. The participants are patients attending the Teaching Care Unit (UDA) of the University of Malaga.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant patients, patients with neurovascular corns, patients diagnosed with rheumatic diseases, patients with inflamatory or neuritis, patients with cognitive disorders who do not understand the questionnaries, patients with a history of traumatic injuries, patients with peripheral neuropathy or peripheral vascular disease, patients allergic to salicylic acid, salicylates or any component of the drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample was calculated with an effect=0.5, alpha=0.05 and power=0.95, resulting in 34 patients for each group intervention. It is planned to used in the study of the statistical analysis the Statistical Package for Social Sciences (SPSS) version 21.0

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2014
Actual
31/03/2014
Date of last participant enrolment
Anticipated
Actual
13/02/2015
Date of last data collection
Anticipated
Actual
27/03/2015
Sample size
Target
68
Accrual to date
Final
62
Recruitment outside Australia
Country [1] 6063 0
Spain
State/province [1] 6063 0
Malaga

Funding & Sponsors
Funding source category [1] 289260 0
Self funded/Unfunded
Name [1] 289260 0
Irene Garcia Paya
Country [1] 289260 0
Spain
Primary sponsor type
University
Name
University of Malaga
Address
Arquitecto Francisco Penalosa (Ampliacion Campus Teatinos)
29071 Malaga
Country
Spain
Secondary sponsor category [1] 287934 0
None
Name [1] 287934 0
Address [1] 287934 0
Country [1] 287934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291033 0
CEUMA: University of Malaga Ethics Committee
Ethics committee address [1] 291033 0
Boulevar Louis Pasteur, Campus Universitario de Teatinos
Malaga
29071
Ethics committee country [1] 291033 0
Spain
Date submitted for ethics approval [1] 291033 0
22/04/2013
Approval date [1] 291033 0
27/02/2014
Ethics approval number [1] 291033 0
2013-0012-H

Summary
Brief summary
This study is a randomized controlled trial in patients with plantar callosities and corns, with pain in the forefoot, which aims to determine the effectiveness of the mechanical corn debridement. It is hoped that information gathered from this project will help to contribute to the body of knowledge to an optimal podiatry treatment aproach to plantar callosities
Trial website
Trial related presentations / publications
Short-term effect of scalpel debridement of plantar callosities versus treatment with salicylic acid patches: The EMEDESCA randomized controlled trial. DOI: 10.1111/1346-8138.13720
Public notes

Contacts
Principal investigator
Name 48546 0
Mrs Irene Garcia-Paya
Address 48546 0
Facultad de Ciencias de la Salud
Arquitecto Francisco Penalosa (Ampliacion Campus de Teatinos)
29071 Malaga
Country 48546 0
Spain
Phone 48546 0
+34 667629289 +34 951952876
Fax 48546 0
Email 48546 0
[email protected]
Contact person for public queries
Name 48547 0
Mrs Irene Garcia-Paya
Address 48547 0
Facultad de Ciencias de la Salud
Arquitecto Francisco Penalosa (Ampliacion Campus de Teatinos)
29071 Malaga
Country 48547 0
Spain
Phone 48547 0
+34 951952876
Fax 48547 0
Email 48547 0
[email protected]
Contact person for scientific queries
Name 48548 0
Mrs Irene Garcia-Paya
Address 48548 0
Facultad de Ciencias de la Salud
Arquitecto Francisco Penalosa (Ampliacion Campus de Teatinos)
29071 Malaga
Country 48548 0
Spain
Phone 48548 0
+34 951952876
Fax 48548 0
Email 48548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12290Ethical approval    366372-(Uploaded-09-12-2020-06-37-16)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Gijon-Nogueron G, Garcia-Paya I, Ortega-Avila AB,... [More Details] 366372-(Uploaded-09-12-2020-06-44-55)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseShort-term effect of scalpel debridement of plantar callosities versus treatment with salicylic acid patches: The EMEDESCA randomized controlled trial.2017https://dx.doi.org/10.1111/1346-8138.13720
N.B. These documents automatically identified may not have been verified by the study sponsor.