Diabetic FootNCT04630795
ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
An observational study of Diabetic Foot, run by Staffordshire University.
Trial summary
Diabetic Foot Ulceration (DFU) is one of the most common complication of diabetes costing the NHS over £970m annually. Management of foot ulcers is time-consuming and expensive with 45% taking more than six months to heal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- ViscoTurf insole
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Dec 2024
- Phase
- Observational
- 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
Study population: The study population are selected from patients of King's diabetic foot clinic who meet the inclusion/exclusion criteria and who are consent to take part.
Who may be able to join
- Type 1 OR Type 2 diabetes
- Over 18
- History of foot ulcer
Who cannot join
- History of recent major lower limb surgery (amputation) or revascularisation and orthopaedic reconstruction over the last 3 months
- Current active foot ulcer
- Not be able to walk unassisted for 15 meters
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Investigation Into the Efficacy of a Patient-specific Turf-Like Insole in Reducing Plantar Pressure and Improving Skin Microcirculation in Patients With Diabetic Neuropathy.
Diabetic Foot Ulceration (DFU) is one of the most common complication of diabetes costing the NHS over £970m annually. Management of foot ulcers is time-consuming and expensive with 45% taking more than six months to heal. Around 25% of patients re-ulcerate in 3 months, 40% within 1 year and 60% within 3 years and patients who have achieved wound closure are generally considered to be in remission rather than healed. A patient presenting with a foot ulcer has a greatly elevated risk of amputation while 80% of amputations can be prevented with the appropriate treatment, such as footwear intervention.
ViscoTurf is a novel, 3D printed, orthotic device designed specifically for this purpose. It emulates the function of natural turf to provide cushioning, optimised offloading and better microcirculation on the vulnerable areas of the plantar surface of the foot. This improves perfusion (the delivery of blood to the capillary bed) in the load bearing regions of the foot where the risk of re-ulceration is very high. An earlier feasibility study established proof-of-concept, showing ViscoTurf achieved a higher and longer-lasting increase in perfusion compared to conventional support structures. ViscoTurf insoles can be automatically designed to the foot size and 3D printed.
The main purpose of this study is to investigate the immediate effect of walking in Viscoturf insole (Turf-Like insoles) on skin perfusion and pressure at the sole of the foot in diabetic patients with history of ulceration. To achieve this, the immediate efficacy (effect as a result of walking for 15 meters) of Viscoturf insole will be assessed and compared to that of the standard flat insole. Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest, while the Standard Insole will be a standard 3D printed flat with NO Turf-like patches.
- Conditions
- Diabetic Foot
- Being tested
- ViscoTurf insole, Control insole
- Keywords
- Biomechanics, perfusion, plantar soft tissue, skin microcirculation,
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViscoTurf insoleDevice
Also called Turf like insole
Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest.
Control insoleDevice
Also called Standard insole
Control Insole will be a standard 3D printed flat insole with NO Turf-like patches.
| Study group | Role | What they receive |
|---|---|---|
| 3D printed insole | Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest, while the Control Insole will be a standard 3D printed flat insole with NO Turf-like patches. Receives: Device: ViscoTurf insole; Device: Control insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar skin perfusion before and after use.
The primary outcome measure is the improvement in plantar skin perfusion, which is the difference between skin perfusion before and after use.
Measured: March-July 2021
Secondary outcomes (1)
Plantar Pressure during walking
The secondary outcome measure is plantar pressure underneath the critical areas when walking in the insole.
Measured: March-July2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Sep 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Staffordshire University
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Principal investigator, Roozbeh Naemi, Staffordshire University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630795
- Sponsor's protocol ID
- SU-20-001
- Status last verified
- Apr 2023
- First submitted
- 13 Nov 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants with diabetes will be recruited from Kings College Hospital Trust (KCHT) using the inclusion and exclusion criteria previously outlined. A dedicated research podiatric practitioner nurse will first identify the patients who meet the inclusion exclusion criteria by searching through the KCHT diabetic foot patient database and clinical records.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Efficacy of a Patient-specific Turf-Like Insole in Reducing Plantar Pressure and Improving Skin Microcirculation in Patients With Diabetic Neuropathy.
- ClinicalTrials.gov ID
- NCT04630795
- Acronym / sponsor ID
- SU-20-001
- Conditions
- Diabetic Foot
- Keywords
- Biomechanics, perfusion, plantar soft tissue, skin microcirculation,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Staffordshire UniversityUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 16 Nov 2020 (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.
Diabetic Foot Ulceration (DFU) is one of the most common complication of diabetes costing the NHS over £970m annually. Management of foot ulcers is time-consuming and expensive with 45% taking more than six months to heal. Around 25% of patients re-ulcerate in 3 months, 40% within 1 year and 60% within 3 years and patients who have achieved wound closure are generally considered to be in remission rather than healed. A patient presenting with a foot ulcer has a greatly elevated risk of amputation while 80% of amputations can be prevented with the appropriate treatment, such as footwear intervention.
ViscoTurf is a novel, 3D printed, orthotic device designed specifically for this purpose. It emulates the function of natural turf to provide cushioning, optimised offloading and better microcirculation on the vulnerable areas of the plantar surface of the foot. This improves perfusion (the delivery of blood to the capillary bed) in the load bearing regions of the foot where the risk of re-ulceration is very high. An earlier feasibility study established proof-of-concept, showing ViscoTurf achieved a higher and longer-lasting increase in perfusion compared to conventional support structures. ViscoTurf insoles can be automatically designed to the foot size and 3D printed.
The main purpose of this study is to investigate the immediate effect of walking in Viscoturf insole (Turf-Like insoles) on skin perfusion and pressure at the sole of the foot in diabetic patients with history of ulceration. To achieve this, the immediate efficacy (effect as a result of walking for 15 meters) of Viscoturf insole will be assessed and compared to that of the standard flat insole. Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest, while the Standard Insole will be a standard 3D printed flat with NO Turf-like patches.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D printed insole | – | Device: ViscoTurf insole, Device: Control insoleIntervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest, while the Control Insole will be a standard 3D printed flat insole with NO Turf-like patches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are selected from patients of King's diabetic foot clinic who meet the inclusion/exclusion criteria and who are consent to take part.
Key inclusion criteria (3 listed)
- Type 1 OR Type 2 diabetes
- Over 18
- History of foot ulcer
Key exclusion criteria (3 listed)
- History of recent major lower limb surgery (amputation) or revascularisation and orthopaedic reconstruction over the last 3 months
- Current active foot ulcer
- Not be able to walk unassisted for 15 meters
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 |
|---|---|---|
| ViscoTurf insoleAlso: Turf like insoleIntervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest. | Device | 3D printed insole |
| Control insoleAlso: Standard insoleControl Insole will be a standard 3D printed flat insole with NO Turf-like patches. | Device | 3D printed insole |
Primary outcome
Plantar skin perfusion before and after use.
Time frame: March-July 2021
The primary outcome measure is the improvement in plantar skin perfusion, which is the difference between skin perfusion before and after use.
1 secondary outcome
Plantar Pressure during walking
Time frame: March-July2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. Participants with diabetes will be recruited from Kings College Hospital Trust (KCHT) using the inclusion and exclusion criteria previously outlined. A dedicated research podiatric practitioner nurse will first identify the patients who meet the inclusion exclusion criteria by searching through the KCHT diabetic foot patient database and clinical records.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by Staffordshire University.
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 3 inclusion and 3 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Roozbeh Naemi, PhD (+441782295879, r.naemi@staffs.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar skin perfusion before and after use. (time frame: March-July 2021). 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 18 Apr 2023.