Diabetes MellitusPROFOUNDNCT03958539
Prevention of Primary Foot Ulcers in High-risk Diabetes Patients
A study testing 3D printed insoles for normal footware in people with Diabetes Mellitus and Foot Ulcer, Diabetic, run by Countess of Chester NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a primary prevention study which aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Foot Ulcer, Diabetic, Primary Prevention
- What is being tested?
- 3D printed insoles for normal footware
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2019to 12 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes (type 1 or 2)
- Aged ≥18
- Peripheral sensory neuropathy assessed by 10-gram monofilament With
- Signs of abnormal loading as indicated by callus formation or hyperaemia Or
- limb ischaemia as evidenced by intermittent claudication /non-palpable pulses / history of vascular intervention Or
- on renal replacement therapy
Who cannot join
- Patients currently prescribed with or in need of therapeutic footwear
- Active or history of foot ulcer
- Active Charcot's neuroarthropathy
- History of major operation in the foot including amputation,
- Local / systemic symptoms of infection, severe illness that would make 12 month survival unlikely
- Unable to provide informed consent
- Inability to follow the study instructions (as judged by the recruiting clinician).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Countess of Chester NHS Trust
Chester, Cheshire, CH2 1UL
About this study
Official title: Prevention of Primary Foot Ulcers in High-risk Diabetes Patients (PrOFoUnD): a Cluster Randomised Trial of 3D Printed Insoles Versus Standard Care
This is a primary prevention study which aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care
Read the detailed description
Once a patient with diabetes develops a foot ulcer 80% are likely to have a lower limb amputation in the future. Amputation carries a considerable burden of cost and impaired quality of life (QOL) and is associated with a 5-year mortality rate of 70%. Once a patient develops an ulcer they remain at high risk for life and are likely to suffer considerable morbidity, debilitation, reduced quality of life and numerous attendances with health care professionals including emergency hospital presentation. There are significant costs associated with the management of diabetes foot ulcers (DFU) which accounts for £1 billion of NHS funding and an average weekly care cost of £208 per person. Both diabetes ulcers and amputation for the most part are preventable providing that patients have effective glycaemic control, regular foot assessments, care for their feet appropriately and wear appropriate footwear or orthotic wear to prevent ulceration.
The focus of this initiative is to utilise digital capability by 3D scanning systems in the community for the provision of highly cost-effective 3D printed soles for shoes which distribute the pressure on the feet whilst having the flexibility of being used in general footwear, thus improving compliance. The cost of these soles is very low at approximately £40 for two pairs. More complex orthotics cost on average £525 each. Scanners and software are likely to be offered free if this is scaled up. The investigators are proposing to work closely with podiatrists in local foot protection services to assess a number of patients at high risk of foot ulcer and deliver a care bundle, which will include assessment, education around both foot care and promoting structured education and 3D sole provision.
The study aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care. The secondary outcome measures will be improvement in standardised QOL measures. 450 diabetes patients with high-risk feet would be recruited who would be prepared to wear the custom made 3D printed insoles on a regular basis (Intervention group). The control group will be formed of 450 diabetes patients with high-risk feet who will receive standard care.
- Conditions
- Diabetes Mellitus, Foot Ulcer, Diabetic, Primary Prevention
- Being tested
- 3D printed insoles for normal footware
- 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.
3D printed insoles for normal footwareDevice
Imprints are low-cost, bespoke, 3D-printed orthotics designed to prevent diabetic foot ulceration by redistributing and lowering peak foot pressures. This is achieved by using different density zones designed specifically for the patient. The patient's foot shape and pressure zone are capture by a 3D imaging system. Once scanned the software automatically identifies the peak pressure zones, matches these with the correct material and stiffness (densities), fits the insole arch to the patient and generates the insole.
The imprints insole is divided into four pressure zones: heel, midfoot, metatarsal head region and toes. These zones are printed with different stiffness to account for the difference in loading between them. The design of the pressure zones is automatically matched to the shape of each individual foot with the help of the 3D scan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | 6 sites out of a total of 12 will act as the intervention sites. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to be provided with bespoke 3-D printed insoles. Receives: Device: 3D printed insoles for normal footware |
| Control | No intervention | 6 sites out of a total of 12 will act as the control sites providing standard care. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of new ulcer in patients with high-risk diabetic feet is our primary outcome measure
Ulcer is defined as any new break in the skin of the feet
Measured: Within 1 year of randomisation
Secondary outcomes (6)
To compare patient satisfaction at baseline 26, and 52 weeks post randomisation
standardised questionnaires
Measured: Within 1 year of randomisation
To evaluate quality of life using NeuroQoL at baseline, 26, and 52 weeks post randomisation
standardised questionnaires
Measured: Within 1 year of randomisation
Incidence of adverse events relating in the 3D insole group over 52 weeks post randomisation
AE event recording
Measured: Within 1 year of randomisation
New callus formation
Clinical examination by podiatrists
Measured: Within 1 year of randomisation
To evaluate quality of life using EQ-5D-3L at baseline, 26, and 52 weeks post randomisation
standardised questionnaires
Measured: Within 1 year of randomisation
Need for debridement of callus
Clinical examination by podiatrists
Measured: Within 1 year of randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Sep 2019
- Primary completion1 Apr 2023
- Study completion12 Feb 2025
Why it stopped: Funding during the pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Model description
- As this study involves a complex intervention in the form of a pathway, we chose a cluster randomisation design to mitigate the risk of contamination across the groups. The podiatry units will find it much easier to follow one pathway for all participants in their sites. We also reduce the cost by halving the number of foot scanners required to be purchased (and the staff training required) for the study by using cluster randomisation.
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Countess of Chester NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, Staffordshire University
- Responsible party
- Sponsor
- Investigators
- Sunil Nair, FRCP, PhD, Principal investigator, Countess of Chester Hospital NHS Trust, Chester, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958539
- Sponsor's protocol ID
- 265590
- Other IDs
- 265590
- Acronym
- PROFOUND
- Status last verified
- Jan 2021
- First submitted
- 15 May 2019
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Primary Foot Ulcers in High-risk Diabetes Patients (PrOFoUnD): a Cluster Randomised Trial of 3D Printed Insoles Versus Standard Care
- ClinicalTrials.gov ID
- NCT03958539
- Acronym / sponsor ID
- PROFOUND / 265590
- Conditions
- Diabetes Mellitus, Foot Ulcer, Diabetic, Primary Prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding during the pandemic
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Countess of Chester NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Liverpool, Staffordshire University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 22 May 2019 (actual)
- 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.
This is a primary prevention study which aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care
Detailed description
Once a patient with diabetes develops a foot ulcer 80% are likely to have a lower limb amputation in the future. Amputation carries a considerable burden of cost and impaired quality of life (QOL) and is associated with a 5-year mortality rate of 70%. Once a patient develops an ulcer they remain at high risk for life and are likely to suffer considerable morbidity, debilitation, reduced quality of life and numerous attendances with health care professionals including emergency hospital presentation. There are significant costs associated with the management of diabetes foot ulcers (DFU) which accounts for £1 billion of NHS funding and an average weekly care cost of £208 per person. Both diabetes ulcers and amputation for the most part are preventable providing that patients have effective glycaemic control, regular foot assessments, care for their feet appropriately and wear appropriate footwear or orthotic wear to prevent ulceration.
The focus of this initiative is to utilise digital capability by 3D scanning systems in the community for the provision of highly cost-effective 3D printed soles for shoes which distribute the pressure on the feet whilst having the flexibility of being used in general footwear, thus improving compliance. The cost of these soles is very low at approximately £40 for two pairs. More complex orthotics cost on average £525 each. Scanners and software are likely to be offered free if this is scaled up. The investigators are proposing to work closely with podiatrists in local foot protection services to assess a number of patients at high risk of foot ulcer and deliver a care bundle, which will include assessment, education around both foot care and promoting structured education and 3D sole provision.
The study aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care. The secondary outcome measures will be improvement in standardised QOL measures. 450 diabetes patients with high-risk feet would be recruited who would be prepared to wear the custom made 3D printed insoles on a regular basis (Intervention group). The control group will be formed of 450 diabetes patients with high-risk feet who will receive standard care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- As this study involves a complex intervention in the form of a pathway, we chose a cluster randomisation design to mitigate the risk of contamination across the groups. The podiatry units will find it much easier to follow one pathway for all participants in their sites. We also reduce the cost by halving the number of foot scanners required to be purchased (and the staff training required) for the study by using cluster randomisation.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Device: 3D printed insoles for normal footware6 sites out of a total of 12 will act as the intervention sites. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to be provided with bespoke 3-D printed insoles. |
| Control | No intervention | –6 sites out of a total of 12 will act as the control sites providing standard care. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of diabetes (type 1 or 2)
- Aged ≥18
- Peripheral sensory neuropathy assessed by 10-gram monofilament With
- Signs of abnormal loading as indicated by callus formation or hyperaemia Or
- limb ischaemia as evidenced by intermittent claudication /non-palpable pulses / history of vascular intervention Or
Key exclusion criteria (7 listed)
- Patients currently prescribed with or in need of therapeutic footwear
- Active or history of foot ulcer
- Active Charcot's neuroarthropathy
- History of major operation in the foot including amputation,
- Local / systemic symptoms of infection, severe illness that would make 12 month survival unlikely
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 |
|---|---|---|
| 3D printed insoles for normal footwareImprints are low-cost, bespoke, 3D-printed orthotics designed to prevent diabetic foot ulceration by redistributing and lowering peak foot pressures. This is achieved by using different density zones designed specifically for the patient. The patient's foot shape and pressure zone are capture by a 3D imaging system. Once scanned the software automatically identifies the peak pressure zones, matches these with the correct material and stiffness (densities), fits the insole arch to the patient and generates the insole. The imprints insole is divided into four pressure zones: heel, midfoot, metatarsal head region and toes. These zones are printed with different stiffness to account for the difference in loading between them. The design of the pressure zones is automatically matched to the shape of each individual foot with the help of the 3D scan. | Device | Intervention arm |
Primary outcome
The incidence of new ulcer in patients with high-risk diabetic feet is our primary outcome measure
Time frame: Within 1 year of randomisation
Ulcer is defined as any new break in the skin of the feet
6 secondary outcomes
To compare patient satisfaction at baseline 26, and 52 weeks post randomisation
Time frame: Within 1 year of randomisation
To evaluate quality of life using NeuroQoL at baseline, 26, and 52 weeks post randomisation
Time frame: Within 1 year of randomisation
Incidence of adverse events relating in the 3D insole group over 52 weeks post randomisation
Time frame: Within 1 year of randomisation
New callus formation
Time frame: Within 1 year of randomisation
To evaluate quality of life using EQ-5D-3L at baseline, 26, and 52 weeks post randomisation
Time frame: Within 1 year of randomisation
Need for debridement of callus
Time frame: Within 1 year of randomisation
Results and safety
The study was stopped early (reason given: Funding during the pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Sunil Nair, FRCP, PhD principal investigator
Countess of Chester Hospital NHS Trust, Chester, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed insoles for normal footware in people with Diabetes Mellitus and Foot Ulcer, Diabetic, run by Countess of Chester NHS Foundation Trust 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 7 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: stopped early, as of the sponsor's last update on 14 Feb 2025. 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?
The study was stopped early (reason given: Funding during the pandemic). Results are not available in the source record.
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?
The incidence of new ulcer in patients with high-risk diabetic feet is our primary outcome measure (time frame: Within 1 year of randomisation). 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 14 Feb 2025.