The CARROT trial: CAllus Reduction Reinforcing Orthotic Therapy

ISRCTN ISRCTN05190231
DOI https://doi.org/10.1186/ISRCTN05190231
Secondary identifying numbers PB-PG-0706-10143
Submission date
01/10/2007
Registration date
15/05/2008
Last edited
04/03/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Philip Helliwell
Scientific

University of Leeds
Academic Unit of Musculoskeletal Disease
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe CARROT trial: CAllus Reduction Reinforcing Orthotic Therapy - the effectiveness of sharp scalpel debridement of callus as a component of complex long-term interventions for painful forefoot plantar callosities in patients with rheumatoid arthritis
Study acronymCARROT
Study hypothesisThis is a randomised controlled trial (RCT) of patients with rheumatoid arthritis (RA) and painful forefoot plantar callosities receiving either debridement of painful forefoot plantar callosities plus conservative therapies or conservative therapies alone.

Hypothesis:
The addition of repeated sharp scalpel debridement of callus to a long-term care plan offers no greater reduction in pain or improvement in functional status than a low-risk, long-term care plan based on conservative self care, footwear advice, padding and/orthoses.
Ethics approval(s)Ethics approval received from the Leeds (West) Research Ethics Committee on the 30th May 2007 (ref: 07/Q1205/70).
ConditionRheumatoid arthritis
InterventionConservative long-term therapies:
Usual conservative long-term therapies will be provided to patients in both the treatment and control arms. Long-term therapies include education and self-management advice, footwear advice, prescription of foot orthoses, referral for orthopaedic footwear, referral to physiotherapy, and intra-articular and soft tissue injection therapy. Patients in the control arm will receive the long-term therapeutic protocol only, while patients in the treatment arm will receive the long-term therapeutic protocol plus sharp scalpel debridement of callosities.

Callus debridement:
Patients in the treatment arm will receive repeat callus debridement in addition to the standard long-term therapy. Debridement will involve regular removal of the callused lesions with a scalpel. The intervals between debridement will be determined by the clinician according to a debridement protocol, and may be altered during the course of the study dependent upon the requirements of the individual patient.
Intervention typeOther
Primary outcome measureForefoot pain measured by 100 mm Visual Analogue Scale (VAS) and the pain subscale of the Foot Function Index (FFI). Patients in both treatment arms will complete pain scores at 6, 12 and 18 weeks (± 2 weeks); and at 6, 9, 12 and 18 months (± 1 month). The Leeds Foot Impact Scale (LFIS) will be used to measure the impact of foot pain, impairment, activity limitation and footwear at baseline, 6 and 12 months and at exit (18 months).
Secondary outcome measures1. Intra-operative haemorrhage, measured at 6, 12 and 18 weeks (± 2 weeks) and at 6, 9, 12 and 18 months (± 1 month)
2. Post-treatment infection and ulceration rates, measured at 6, 12 and 18 weeks (± 2 weeks) and at 6, 9, 12 and 18 months (± 1 month)
3. Number of clinical appointments required, measured at 6, 12 and 18 weeks (± 2 weeks) and at 6, 9, 12 and 18 months (± 1 month)
4. Temporal and spacial parameters of gait (measured at baseline and exit visit only) and forefoot plantar pressures, measured at 6, 12 and 18 weeks (± 2 weeks) and at 6, 9, 12 and 18 months (± 1 month)
Overall study start date15/10/2007
Overall study end date15/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants64
Participant inclusion criteria1. Positive diagnosis of RA (American Rheumatology Association [ARA]/American College of Rheumatology [ACR] classification 1987)
2. One or more painful forefoot plantar callosities (including corns)
3. Willingness to participate in trial for 18 months
4. Participants aged more than or equal to 16, male and female
Participant exclusion criteria1. Co-morbidity which would place the patient at risk if randomised to the control arm, e.g. diabetes mellitus, peripheral arterial insufficiency, loss of protective sensation, existing risk/presence of ulceration/extravasation at baseline
2. History of routine podiatric intervention including callus debridement on two or more occasions in the previous 12 months
Recruitment start date15/10/2007
Recruitment end date15/10/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Leeds
Leeds
LS2 9NZ
United Kingdom

Sponsor information

Leeds Teaching Hospital NHS Trust (UK)
Hospital/treatment centre

Research Development Office
Floor A/B, Old Site
Great George Street
Leeds
LS1 3EX
England
United Kingdom

+44 (0)113 392 2878
derek.norfolk@leedsth.nhs.uk
http://www.leedsteachinghospitals.com/
ROR logo https://ror.org/00v4dac24

Funders

Funder type

Government

Department of Health (UK) - Research for Patient Benefit Scheme

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2013 Yes No
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