The CARROT trial: CAllus Reduction Reinforcing Orthotic Therapy

The 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN05190231

Enrollment

Registered

2008-05-15

Start date

2007-10-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis

Interventions

Conservative 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

Measure	Time frame
Forefoot 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).	—

Measure

Time frame

Forefoot 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).

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Secondary

Measure	Time frame
1. 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)	—

Measure

Time frame

1. 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)

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026