A Comparison of Insoles Used to Prevent Neuropathic Diabetic Foot Ulceration

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00999635
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : October 27, 2009
Cornwall and Illes of Scilly Primary Care Trust
Plymouth Teaching Primary Care Trust
Diabetes UK
Information provided by:
University of Plymouth

Brief Summary:

Importance of the topic:

Lower extremity amputation is a costly complication of diabetes for both the NHS and the patient. Amputation may be avoided if the preceding foot ulceration can be prevented. One method of reducing the risk of ulceration in the neuropathic foot is through the provision of therapeutic insoles. The type of insole prescribed (prefabricated verses custom made) is currently based on anecdotal evidence. The idea held by many practitioners that the custom made insole is superior in its effect remains speculation, unsupported by the evidence. In the absence of economic analysis, the available data suggests that the custom insole is substantially more expensive to the NHS. This study, to determine which of two types of insole used in therapeutic shoes reduces peak pressure more in the at−risk diabetic foot, is therefore a very important topic and will provide both useful evidence for the NHS podiatry services. It is of course also very important for patients with diabetes as the personal suffering of those undergoing amputation is immense.

The study is a single blind randomised controlled trial comparing custom made with 'off the shelf' insoles.

Condition or disease Intervention/treatment Phase
Diabetes Neuropathic Foot Device: Insole Phase 2 Phase 3

Detailed Description:

Aim The study compared custom-made functional insoles with prefabricated insoles for the preventative management of neuropathic diabetic feet, assessing effects on peak pressure, forefoot pressure time integral, total contact area, forefoot rate of loading, duration of load as a percentage of stance, quality of life, perceived foot health and cost.

Method Pilot work investigating the physical properties of materials used to fabricate insoles informed material selection. A single-blind randomised control trial recruited 119 neuropathic participants with diabetes from two Primary Care Trusts and randomly allocated them to either custom-made functional insoles or prefabricated insoles. Data was collected at issue and 6-month follow-up, using the F-scan in-shoe pressure measurement system. Patient perceptions were assessed with the Bristol Foot Score and Audit of Diabetes Dependant Quality of Life. Further analyses were carried out on two subgroups; 1) insole effect on peak pressure in 44 participants with pronated feet, over a 6-month follow-up period; 2) insole durability, investigated in a second subgroup of 60 participants for 12-months. Durability was evaluated in terms of change in insole thickness and reduction in peak pressure.

To increase the robustness of results, data analysis was calculated using three strategies; 1) pure intention-to-treat analysis, including all 119 participants randomised to an intervention; 2) intention-to-treat analysis, using all available data; 3) as-treated analysis, including those participants self-reporting full insole compliance, defined as 60% or more daytime wear.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Comparison of Functional and Prefabricated Insoles Used for the Preventative Management of Neuropathic Diabetic Foot Ulceration: a Single Blind Randomised Control Trial
Study Start Date : March 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Custom made insole
Custom made functional moulded insole
Device: Insole
Comparison of custom made and prefabricated insoles designed for the neuropathic diabetic foot, issued for day time wear and followed for a 6 month period
Active Comparator: Prefabricated Insole
Prefabricated accommodative moulded insole
Device: Insole
Comparison of custom made and prefabricated insoles designed for the neuropathic diabetic foot, issued for day time wear and followed for a 6 month period

Primary Outcome Measures :
  1. Reduction in peak pressure [ Time Frame: 6-months ]

Secondary Outcome Measures :
  1. Comparison of cost [ Time Frame: 6-months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosed as having Type 1 or 2 diabetes mellitus, (recorded within the case notes and confirmed by participant),
  • diagnosed with diabetic peripheral neuropathy
  • palpable or biphasic pulses
  • intact from lower limb vascular or neuropathic ulceration, scoring Grade 0 on the Wagner classification for foot ulcer
  • able to walk a minimum of 10 metres unaided
  • willing to comply with the requirements of the study.

Exclusion Criteria:

  • presented with current or recently healed ulceration less than 6 months prior to study enrolment,
  • severe fixed mid-foot or rearfoot deformity e.g. charcot joint, unsuitable for prefabricated insoles and non- bespoke footwear,
  • history of major bone or joint surgery of the lower limb including major amputation
  • unable to comprehend simple instructions and comply with the study protocols and procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00999635

United Kingdom
Liskeard Community Hospital
Liskeard, Cornwall, United Kingdom
Local Care Center Mount Gould
Plymouth, Devon, United Kingdom
Sponsors and Collaborators
University of Plymouth
Cornwall and Illes of Scilly Primary Care Trust
Plymouth Teaching Primary Care Trust
Diabetes UK
Study Director: Ray Jones, Professor University of Plymouth
Principal Investigator: Joanne Paton, PhD University of Plymouth

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Joanne Paton, University of Plymouth Identifier: NCT00999635     History of Changes
Other Study ID Numbers: 05/Q2103/150
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by University of Plymouth:
Prevention of Ulceration
Diabetic Foot

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Pathologic Processes
Foot Diseases