The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12606000176561
Ethics application status
Approved
Date submitted
12/05/2006
Date registered
15/05/2006
Date last updated
21/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of debridement of painful plantar calluses in older people
Scientific title
Effectiveness of scalpel debridement for the treatment of painful plantar calluses in older people: a randomised trial evaluating pain, plantar pressures and functional ability
Secondary ID [1] 288388 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Painful plantar callus (hyperkeratosis) 1149 0
Condition category
Condition code
Skin 1229 1229 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Scalpel debridement versus sham scalpel debridement of plantar callus
The intervention period is six weeks.
(Scalpel debridement = removal or reduction of the callus by using a scalpel or sharp blade)
Intervention code [1] 1036 0
Treatment: Other
Intervention code [2] 293695 0
Treatment: Other
Comparator / control treatment
Sham scalpel debridement of plantar callus. The intervention period is six weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 1668 0
Change in pain
Timepoint [1] 1668 0
Immediately post debridement and then at 1-, 3- and 6-weeks.
Secondary outcome [1] 2986 0
Change in pain
Timepoint [1] 2986 0
At 2, 4, and 5 weeks.
Secondary outcome [2] 2987 0
Change in plantar pressures
Timepoint [2] 2987 0
Immediately after debridement and then at 6-weeks post debridement.
Secondary outcome [3] 2988 0
Change in functional tests (maximum balance range, speed to walk 6 metres, timed sit to stand test and timed alternate step test).
Timepoint [3] 2988 0
Immediately after debridement and then at 6-weeks post debridement.

Eligibility
Key inclusion criteria
Have painful plantar forefoot callus that has not been treated in the past 6 weeks•Callus must register at least 20mm on a 100mm visual analogue scale.
Minimum age
65 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ability to complete the tests associated with the study (i.e. would score greater than 7 on the Short Portable Mental Status Questionnaire)•Inability to walk household distances without an aid•Has received foot orthoses in the past 2 months or will receive in the 6 week intervention period any in-shoe device that could alter the effect of the intervention•Any neurological condition that may effect sensation of the plantar surface (sole) of the feet (e.g. peripheral neuropathy associated with diabetes mellitus)•Inflammatory conditions affecting the feet (e.g. inflammatory arthritis)•History of plantar forefoot ulceration in the past 3 months•Any foreign bodies in the foot that may be causing pain•Foot amputation other than amputation of a digit or digits.

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)
Sequentially numbered opaque (including aluminium foil) sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated (using Microsoft Excel)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1343 0
University
Name [1] 1343 0
La Trobe University Faculty of Health Starter Grant
Address [1] 1343 0
La Trobe University
Vic, 3086
Country [1] 1343 0
Australia
Primary sponsor type
Individual
Name
Dr Karl B Landorf
Address
La Trobe University
Vic, 3086
Country
Australia
Secondary sponsor category [1] 1184 0
Individual
Name [1] 1184 0
Dr Hylton B Menz
Address [1] 1184 0
La Trobe University
Vic, 3086
Country [1] 1184 0
Australia
Secondary sponsor category [2] 1185 0
Individual
Name [2] 1185 0
Adam Bird
Address [2] 1185 0
La Trobe University
Vic, 3086
Country [2] 1185 0
Australia
Secondary sponsor category [3] 1186 0
Individual
Name [3] 1186 0
Chelsey Nash
Address [3] 1186 0
La Trobe University
Vic, 3086
Country [3] 1186 0
Australia
Secondary sponsor category [4] 1187 0
Individual
Name [4] 1187 0
Anna Novak
Address [4] 1187 0
La Trobe University
Vic, 3086
Country [4] 1187 0
Australia
Secondary sponsor category [5] 1188 0
Individual
Name [5] 1188 0
Martin Spink
Address [5] 1188 0
La Trobe University
Vic, 3086
Country [5] 1188 0
Australia
Secondary sponsor category [6] 1189 0
Individual
Name [6] 1189 0
Dr Julia Potter
Address [6] 1189 0
La Trobe University
Vic, 3086
Country [6] 1189 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2696 0
La Trobe University
Ethics committee address [1] 2696 0
Ethics committee country [1] 2696 0
Australia
Date submitted for ethics approval [1] 2696 0
Approval date [1] 2696 0
01/05/2006
Ethics approval number [1] 2696 0
FHEC06/25

Summary
Brief summary
The aim of this project is to evaluate the effectiveness of reducing painful callus (hard skin) on the bottom of the feet (using scalpel debridement) versus no reduction (using a sham debridement technique).
This study is double-blind: both the participants and the assessors will be blinded.
Trial website
Trial related presentations / publications
Journal article
Landorf KB, Morrow A, Spink MJ, Nash CL, Novak A, Potter J, Menz HB: Effectiveness of scalpel debridement for painful plantar calluses in older people: a randomized trial. Trials 2013, 14:243.
Public notes

Contacts
Principal investigator
Name 35496 0
A/Prof Karl Landorf
Address 35496 0
Discipline of Podiatry
School of Allied Health
La Trobe University
Vic, 3086
Country 35496 0
Australia
Phone 35496 0
+613 9479 5300
Fax 35496 0
Email 35496 0
k.landorf@latrobe.edu.au
Contact person for public queries
Name 10225 0
A/Prof Dr Karl B Landorf
Address 10225 0
Discipline of Podiatry
School of Allied Health
La Trobe University
Vic, 3086
Country 10225 0
Australia
Phone 10225 0
(03) 9479 5300
Fax 10225 0
(03) 9479 5784
Email 10225 0
k.landorf@latrobe.edu.au
Contact person for scientific queries
Name 1153 0
A/Prof Dr Karl B Landorf
Address 1153 0
Discipline of Podiatry
School of Allied Health
La Trobe University
Vic, 3086
Country 1153 0
Australia
Phone 1153 0
(03) 9479 5300
Fax 1153 0
(03) 9479 5784
Email 1153 0
k.landorf@latrobe.edu.au