DiabeticNCT01948479
Insole Optimisation for Ulcer Prevention: a Feasibility Trial
A study testing Optimised instant offloading insole in people with Diabetic and Neuropathic, run by University of Plymouth at 1 site in United Kingdom.
Trial summary
Insoles are designed to reduce increased loads and re-ulceration risk in patients with diabetes. The investigators previous research findings suggest that an instant insole solution may benefit some, but effectiveness is difficult to predict. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic, Neuropathic, Past Ulceration
- What is being tested?
- Optimised instant offloading insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 30 years or above
- Diagnosed with Diabetes Mellitus
- Recently healed/healing target ulcer on the weight-bearing surface of the foot
- Neuropathic (Mild to moderate DPN defined as insensitivity of a 10 g monofilament at 1-3 sites in the following locations: hallux, 1st, 3rd, and 5th metatarsal heads (Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, Lemaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK: Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care 2008;31:1679-1685)
- Able (in the Investigators opinion) and willing to comply with all study requirements
Who cannot join
- The participant may not enter the study if ANY of the following apply: Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- None healing foot ulcer at another site that requires targeted off-loading.
- Unable to walk 5 metres with/without walking aid
- Peripheral vascular disease (non-re-constructible vascular disease as determined by arterial duplex and clinically assessed by a vascular consultant)
- Unwilling to wear therapeutic footwear
- Where amputation has been part of the current episode of care and includes ulceration site.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Derriford Hospital
Plymouth, Devon, PL6 8BH
Graham Bruce, grahambruce1@nhs.net
Graham Bruce
About this study
Official title: Prevention of Foot Ulcer Recurrence in People With Diabetes Using an In-shoe Pressure Measurement Technology: A Randomised Control Trial Feasibility Study
Insoles are designed to reduce increased loads and re-ulceration risk in patients with diabetes. The investigators previous research findings suggest that an instant insole solution may benefit some, but effectiveness is difficult to predict. The investigators propose a feasibility study using in-shoe pressure analysis to optimise the protective effect of insoles and footwear with the aim of reducing re-ulceration rates.
Early indications from exploratory case studies within the real world clinical setting suggest that by implementing the investigators previous published research findings the investigators can optimise effectiveness and reduce outcome variability of protective footwear and insoles provided to patients at risk of re-ulceration.
However a further randomised control trial is necessary to evaluate the effectiveness of in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear provision or 2) Routine insole and footwear provision, and temporary insole provision with optimisation. The findings from the feasibility study will inform protocol development for a larger clinical trial. The results of the feasibility study will be used to strengthen a protocol for a grant application to conduct the main RCT. A secondary output from the pilot study will be the dissemination of findings in a peer reviewed journal and at conference.
- Conditions
- Diabetic, Neuropathic, Past Ulceration
- Being tested
- Optimised instant offloading insole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimised instant offloading insoleDevice
| Study group | Role | What they receive |
|---|---|---|
| Insole optimised with inshoe analysis | Experimental | Not described Receives: Device: Optimised instant offloading insole |
| Routine insole provision | Active comparator | Not described Receives: Device: Optimised instant offloading insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcer recurrence rates
Measured: 6 months
Secondary outcomes (1)
peak pressure reduction with the addition of the intervention
Measured: Issue and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabeticStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Plymouth NHS Trust
- Responsible party
- Principal investigator, Joanne Paton, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948479
- Sponsor's protocol ID
- PatonRCT02
- Status last verified
- Sep 2013
- First submitted
- 18 Sep 2013
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Foot Ulcer Recurrence in People With Diabetes Using an In-shoe Pressure Measurement Technology: A Randomised Control Trial Feasibility Study
- ClinicalTrials.gov ID
- NCT01948479
- Acronym / sponsor ID
- PatonRCT02
- Conditions
- Diabetic, Neuropathic, Past Ulceration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- University Hospital Plymouth NHS Trust
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 23 Sep 2013 (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.
Insoles are designed to reduce increased loads and re-ulceration risk in patients with diabetes. The investigators previous research findings suggest that an instant insole solution may benefit some, but effectiveness is difficult to predict. The investigators propose a feasibility study using in-shoe pressure analysis to optimise the protective effect of insoles and footwear with the aim of reducing re-ulceration rates.
Early indications from exploratory case studies within the real world clinical setting suggest that by implementing the investigators previous published research findings the investigators can optimise effectiveness and reduce outcome variability of protective footwear and insoles provided to patients at risk of re-ulceration.
However a further randomised control trial is necessary to evaluate the effectiveness of in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear provision or 2) Routine insole and footwear provision, and temporary insole provision with optimisation. The findings from the feasibility study will inform protocol development for a larger clinical trial. The results of the feasibility study will be used to strengthen a protocol for a grant application to conduct the main RCT. A secondary output from the pilot study will be the dissemination of findings in a peer reviewed journal and at conference.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insole optimised with inshoe analysis | Experimental | Device: Optimised instant offloading insole |
| Routine insole provision | Active comparator | Device: Optimised instant offloading insole |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 30 years or above
- Diagnosed with Diabetes Mellitus
- Recently healed/healing target ulcer on the weight-bearing surface of the foot
- Neuropathic (Mild to moderate DPN defined as insensitivity of a 10 g monofilament at 1-3 sites in the following locations: hallux, 1st, 3rd, and 5th metatarsal heads (Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, Lemaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK: Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care 2008;31:1679-1685)
Key exclusion criteria (6 listed)
- The participant may not enter the study if ANY of the following apply: Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- None healing foot ulcer at another site that requires targeted off-loading.
- Unable to walk 5 metres with/without walking aid
- Peripheral vascular disease (non-re-constructible vascular disease as determined by arterial duplex and clinically assessed by a vascular consultant)
- Unwilling to wear therapeutic footwear
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 |
|---|---|---|
| Optimised instant offloading insole | Device | Insole optimised with inshoe analysis, Routine insole provision |
Primary outcome
ulcer recurrence rates
Time frame: 6 months
1 secondary outcome
peak pressure reduction with the addition of the intervention
Time frame: Issue and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimised instant offloading insole in people with Diabetic and Neuropathic, run by University of Plymouth at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanne Paton, PhD (01752 588845, joanne.paton@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ulcer recurrence rates (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2013.