Diabetes Mellitus Foot UlcerNCT05604352
Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.
A study testing DiaSole in people with Diabetes Mellitus Foot Ulcer, run by Kaydiar Ltd.
Trial summary
Offloading plays an important part Diabetic foot ulcers healing. The modular design of the DiaSole would allow the offloading cavity to be changed in line with the changing ulcer dimensions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Foot Ulcer
- What is being tested?
- DiaSole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 15 May 2023
- 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
- Age 18 years and above
- Capacity to consent
- UK Shoe size 3-11
- Diagnosis of Diabetes
- Sensory neuropathy (lack of perception of 10g monofilament in one or more sites of the feet)
- Active foot ulceration (plantar aspect), grade 1a using the University of Texas wound grading system (grade 1a)
- Appropriate footwear (which has room to safely accommodate the DiaSole insole)
- At risk of ulceration or re-ulceration (Grade 0A)
Who cannot join
- Patients who are non-concordant and do not have appropriate footwear that could house the DiaSole insole
- Clinical signs of or confirmed active infection (soft tissue or osteomyelitis)
- History of or active Charcot foot or severe foot deformity
- Amputation
- Critical limb ischemia or diagnosed moderate to severe peripheral arterial disease
- Inappropriate footwear (does not accommodate the DiaSole insole)
Show all 16Show fewer
- Visual impairment (cannot see feet and footwear properly)
- Sensory neuropathy of the upper limbs/hands
- History of drug and alcohol abuse• Have known contraindications to the materials used in the product insoles. Allergies to cotton or silicone
- Have an infectious disease, which may pose as a potential risk to the researchers and clinicians
- Are enrolled into another study
- Unable to attend regular hospital visits - e.g. housebound
- Are unwilling to take part in the study
- Are currently enrolled in any other research
- Individuals who do not adequately understand verbal explanations of written information in English, unless there is access to a qualified translator
- Are not suitable for the evaluation, according to the podiatrist's or nurse's clinical judgement
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Extended Phase 2 Product Evaluation Single Sample Study - To Evaluate the Safety of the DiaSole Insole for Use on Patients With Diabetic Foot Ulcers
Offloading plays an important part Diabetic foot ulcers healing. The modular design of the DiaSole would allow the offloading cavity to be changed in line with the changing ulcer dimensions. It may be possible to use the DiaSole for other causes of neuropathic foot ulcerations (such as rheumatoid arthritis), but the safety of the insole needs assessing first. There is already evidence to support the use of offloading insoles in the healing and prevention of pressure ulcers, DiaSole may be an improved insole for this purpose.
Read the detailed description
DiaSole is an insole developed to aid the treatment of diabetic foot ulcers through offloading. Offloading (reducing pressure) plays an integral role in the treatment of diabetic ulcers. DiaSole is modular in construction comprising of many 'cells', which can be individually removed to create the offloading cavity.
This study aims to evaluate the safety of DiaSole with diabetic patients who have superficial ulcers. The ulcer severity of patients included will not involve tendon, capsule or bone, or will be pre or post ulceration and have healed skin integrity (Texas wound classification 1A and 0A respectively).
The study will be conducted within Hywel Dda University Health Board (HDUHB) Podiatry services. Participants will be seen in clinic by the podiatrists emplyed within HDUHB. The patients who consent to take part will be issued a DiaSole insole as part of their usual care and under guidance of the podiatrist. The participants will be instructed to use the DiaSole as part of their ulcer offloading, for an 8-week period.
The primary outcome of this study is to assess the safety of the DiaSole insole with patients who have diabetic neuropathy and are at risk of a pressure ulcer in the feet and/or who have a superficial pressure ulcer. All adverse events and serious adverse events will be documented and used to assess the safety of DiaSole.
During the 8-week period the participants will have photographs taken of their pressure ulcer sites so that any changes to its size can be monitored. The depth of the ulcer will also be measured using a probe. The ulcer dimensions will be monitored as a secondary outcome and data will be collected during the first appointment, then again at weeks 1,2,3,4 and then week 8.
An evaluation form will also be used to capture clinician and patient feedback regarding acceptability at week 8.
- Conditions
- Diabetes Mellitus Foot Ulcer
- Being tested
- DiaSole
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaSoleDevice
Diabetic ulcer offloading insole
| Study group | Role | What they receive |
|---|---|---|
| Main study | Experimental | Study to investigate the safety and clinical efficacy of the DiaSole insole. Receives: Device: DiaSole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the safety of the DiaSole insole
Recording adverse events
Measured: 8-weeks per patient
Secondary outcomes (2)
Clinical efficacy of DiaSole insole
Assessing wound closure area (mm2)
Measured: 8-weeks per patient
acceptability of DiaSole to health care professionals (HCPs)
Survey based feedback from HCPs
Measured: 8-weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion28 Apr 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Foot UlcerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single sample, no randomisation, no blinding.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaydiar Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604352
- Sponsor's protocol ID
- CVT001_Protocol
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No patient identifiable information will be shared outside of the direct care team or the research team.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Phase 2 Product Evaluation Single Sample Study - To Evaluate the Safety of the DiaSole Insole for Use on Patients With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05604352
- Acronym / sponsor ID
- CVT001_Protocol
- Conditions
- Diabetes Mellitus Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kaydiar LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 28 Apr 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 3 Nov 2022 (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.
Offloading plays an important part Diabetic foot ulcers healing. The modular design of the DiaSole would allow the offloading cavity to be changed in line with the changing ulcer dimensions. It may be possible to use the DiaSole for other causes of neuropathic foot ulcerations (such as rheumatoid arthritis), but the safety of the insole needs assessing first. There is already evidence to support the use of offloading insoles in the healing and prevention of pressure ulcers, DiaSole may be an improved insole for this purpose.
Detailed description
DiaSole is an insole developed to aid the treatment of diabetic foot ulcers through offloading. Offloading (reducing pressure) plays an integral role in the treatment of diabetic ulcers. DiaSole is modular in construction comprising of many 'cells', which can be individually removed to create the offloading cavity.
This study aims to evaluate the safety of DiaSole with diabetic patients who have superficial ulcers. The ulcer severity of patients included will not involve tendon, capsule or bone, or will be pre or post ulceration and have healed skin integrity (Texas wound classification 1A and 0A respectively).
The study will be conducted within Hywel Dda University Health Board (HDUHB) Podiatry services. Participants will be seen in clinic by the podiatrists emplyed within HDUHB. The patients who consent to take part will be issued a DiaSole insole as part of their usual care and under guidance of the podiatrist. The participants will be instructed to use the DiaSole as part of their ulcer offloading, for an 8-week period.
The primary outcome of this study is to assess the safety of the DiaSole insole with patients who have diabetic neuropathy and are at risk of a pressure ulcer in the feet and/or who have a superficial pressure ulcer. All adverse events and serious adverse events will be documented and used to assess the safety of DiaSole.
During the 8-week period the participants will have photographs taken of their pressure ulcer sites so that any changes to its size can be monitored. The depth of the ulcer will also be measured using a probe. The ulcer dimensions will be monitored as a secondary outcome and data will be collected during the first appointment, then again at weeks 1,2,3,4 and then week 8.
An evaluation form will also be used to capture clinician and patient feedback regarding acceptability at week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single sample, no randomisation, no blinding.
| Arm | Type | Receives |
|---|---|---|
| Main study | Experimental | Device: DiaSoleStudy to investigate the safety and clinical efficacy of the DiaSole insole. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years and above
- Capacity to consent
- UK Shoe size 3-11
- Diagnosis of Diabetes
- Sensory neuropathy (lack of perception of 10g monofilament in one or more sites of the feet)
Key exclusion criteria (16 listed)
- Patients who are non-concordant and do not have appropriate footwear that could house the DiaSole insole
- Clinical signs of or confirmed active infection (soft tissue or osteomyelitis)
- History of or active Charcot foot or severe foot deformity
- Amputation
- Critical limb ischemia or diagnosed moderate to severe peripheral arterial disease
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 |
|---|---|---|
| DiaSoleDiabetic ulcer offloading insole | Device | Main study |
Primary outcome
Assessing the safety of the DiaSole insole
Time frame: 8-weeks per patient
Recording adverse events
2 secondary outcomes
Clinical efficacy of DiaSole insole
Time frame: 8-weeks per patient
acceptability of DiaSole to health care professionals (HCPs)
Time frame: 8-weeks per patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No. No patient identifiable information will be shared outside of the direct care team or the research team.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Questions about this trial
What is this clinical trial studying?
A study testing DiaSole in people with Diabetes Mellitus Foot Ulcer, run by Kaydiar Ltd.
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 8 inclusion and 16 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 3 Nov 2022. 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 David J Barton, BSc(hons) (07552140218, david@kaydiar.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the safety of the DiaSole insole (time frame: 8-weeks per patient). 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 3 Nov 2022.