NCT00999635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline
Completed

Started Mar 2006

Typical duration for phase_2 diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

1.5 years

First QC Date

October 21, 2009

Last Update Submit

October 23, 2009

Conditions

DiabetesNeuropathic Foot

Keywords

InsolesPrevention of UlcerationDiabetic FootNeuropathic

Outcome Measures

Primary Outcomes (1)

  • Reduction in peak pressure

    6-months

Secondary Outcomes (1)

  • Comparison of cost

    6-months

Study Arms (2)

Custom made insole

EXPERIMENTAL

Custom made functional moulded insole

Device: Insole

Prefabricated Insole

ACTIVE COMPARATOR

Prefabricated accommodative moulded insole

Device: Insole

Interventions

InsoleDEVICE

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

Custom made insolePrefabricated Insole

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liskeard Community Hospital

Liskeard, Cornwall, United Kingdom

Location

Local Care Center Mount Gould

Plymouth, Devon, United Kingdom

Location

Related Publications (1)

  • Paton JS, Stenhouse EA, Bruce G, Zahra D, Jones RB. A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial. J Foot Ankle Res. 2012 Dec 5;5(1):31. doi: 10.1186/1757-1146-5-31.

    PMID: 23216959DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Ray Jones, Professor

    University of Plymouth

    STUDY DIRECTOR

  • Joanne Paton, PhD

    University of Plymouth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 22, 2009

Study Start

March 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2008

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

GB(2)