DiabetesPhase 2/3NCT00999635
A Comparison of Insoles Used to Prevent Neuropathic Diabetic Foot Ulceration
A Phase 2/3 study testing Insole in people with Diabetes and Neuropathic Foot, run by University of Plymouth at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Neuropathic Foot
- What is being tested?
- Insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2006to Sep 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Liskeard Community Hospital
Liskeard, Cornwall
Local Care Center Mount Gould
Plymouth, Devon
About this study
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
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.
Read the 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.
- Conditions
- Diabetes, Neuropathic Foot
- Being tested
- Insole
- Keywords
- Insoles, Prevention of Ulceration, Diabetic Foot, Neuropathic
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Custom made insole | Experimental | Custom made functional moulded insole Receives: Device: Insole |
| Prefabricated Insole | Active comparator | Prefabricated accommodative moulded insole Receives: Device: Insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in peak pressure
Measured: 6-months
Secondary outcomes (1)
Comparison of cost
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startMar 2006
- Primary completionSep 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- Cornwall and Illes of Scilly Primary Care Trust, Plymouth Teaching Primary Care Trust, Diabetes UK
- Investigators
- Ray Jones, Professor, Study director, University of PlymouthJoanne Paton, PhD, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999635
- Sponsor's protocol ID
- 05/Q2103/150
- Status last verified
- Oct 2009
- First submitted
- 21 Oct 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23216959
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00999635
- Acronym / sponsor ID
- 05/Q2103/150
- Conditions
- Diabetes, Neuropathic Foot
- Keywords
- Insoles, Prevention of Ulceration, Diabetic Foot, Neuropathic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- Cornwall and Illes of Scilly Primary Care Trust, Plymouth Teaching Primary Care Trust, Diabetes UK
- Study start
- Mar 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom made insole | Experimental | Device: InsoleCustom made functional moulded insole |
| Prefabricated Insole | Active comparator | Device: InsolePrefabricated accommodative moulded insole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsoleComparison of custom made and prefabricated insoles designed for the neuropathic diabetic foot, issued for day time wear and followed for a 6 month period | Device | Custom made insole, Prefabricated Insole |
Primary outcome
Reduction in peak pressure
Time frame: 6-months
1 secondary outcome
Comparison of cost
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
- Derived from this study: PubMed 23216959Paton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray Jones, Professor study director
University of Plymouth
Joanne Paton, PhD principal investigator
University of Plymouth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Insole in people with Diabetes and Neuropathic Foot, run by University of Plymouth at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in peak pressure (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2009.