Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Joanne Paton


Contact details

FF21 Peninsula Allied Health Centre
University of Plymouth
Derriford Road
United Kingdom
+44 1752 238845

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

To determine whether therapeutic shoes used with 2 types of inserts reduce peak pressure in the at-risk diabetic foot, and to determine which of the orthotics is most effective.

Ethics approval

Added 29 July 2008:
Ethical approval was granted by Cornwall and Plymouth Research Ethics Committee on 24/01/2006, prior to the commencement of recruitment.

Study design

Single blind randomised controlled trial.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Nutritional, Metabolic, Endocrine: Diabetes


The participants will be taken from both referrals and the existing caseload of the North and East Cornwall PCT Podiatry Service and Plymouth PCT podiatry service. Each participant will be required to complete a questionnaire and sign a consent form before taking part in the study. Each participant will receive a diabetic assessment of the lower limb to determine if they present with an increased risk of foot ulceration. Identification of the increased-risk foot include a neurological foot assessment. Each participant will be randomly assigned to one of two groups:
Group 1 will receive 2 pairs of orthopaedic shoes and a custom made moulded insert
Group 2 will receive 2 pairs of orthopaedic shoes and inlay

Intervention type



Not Specified

Drug names

Primary outcome measures

Plantar peak pressure for the entire plantar surface during the stance phase of gait.

Secondary outcome measures

Added 29 July 2008:
1. Forefoot pressure time integral
2. Total contact area
3. Rate of forefoot loading
4. Duration of load as a percentage of stance
5. Perceived foot health
6. Quality of life
7. Cost

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. The subject must be diagnosed as type I or II diabetic
2. The subject must be identified as neuropathic and at risk of ulceration
3. The subject must not currently be suffering from any lower limb vascular or neuropathic ulceration identified by scoring Grade 0 on the Wagner classification for foot ulcer
4. The subject must be ambulant. Must be able to walk a minimum of approximately 10 metres unaided
5. The subject must be willing to comply with the requirements of the study

Participant type


Age group

Not Specified


Not Specified

Target number of participants

Sample size estimate n=130. 65 participants in each group.

Participant exclusion criteria

1. Subjects with current ulceration or recently healed less than 6 months prior to enrolling onto the study (as the focus of the study is preventative ulcer management rather than treatment)
2. Subjects with severe fixed midfoot or rearfoot deformity ie Charcot joint (subjects would be unsuitable for prefabricated insoles and non-bespoke footwear)
3. Subjects with a history of bone and joint surgery of the lower limb including amputation (could lead to alteration in gait kinetics and may not be suitable for non bespoke insoles and footwear)
4. Subjects lacking the ability to comprehend simple instructions and comply with the study protocols and procedures (including those not able to read printed English)
5. Allied Health Professional students as they may be considered to have a dependant relationship with the investigator
6. Subjects diagnosed as neuropathic caused by pathology other than diabetes

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

FF21 Peninsula Allied Health Centre
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

Plymouth Primary Care Trust - Exeter PCT (UK) NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 systematic review in

Publication citations

  1. Systematic review

    Paton J, Bruce G, Jones R, Stenhouse E, Effectiveness of insoles used for the prevention of ulceration in the neuropathic diabetic foot: a systematic review., J. Diabetes Complicat., 25, 1, 52-62, doi: 10.1016/j.jdiacomp.2009.09.002.

Additional files

Editorial Notes