DiabetesPhase 1GekoNCT02378909
Wound Healing Process in Diabetic Neuropathy and Diabetic Neuroischemia
A Phase 1 study testing Electrical stimulation device. in people with Diabetes, run by University of Manchester.
Trial summary
Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect nerves, skin and blood vessels. Diabetics with problems in their nerves can lose the sense of touch in their feet (called neuropathy) and so may unknowingly cause damage to the skin resulting in skin loss or an 'ulcer'. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Electrical stimulation device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2016
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients with Type 1 or 2 diabetes.
- Male or female, aged 18-85 years.
- Presence of significant neuropathic ulcers.
- Presence of significant neuroischaemic ulcers.
- Patients who are able and willing to follow the protocol requirements.
Who cannot join
- Unreliable, unwilling or unable to comprehend informed consent.
- Patients with recently diagnosed or with suspected deep vein thrombosis (DVT).
- Patients without neuroischaemic/ neuropathic ulcers
- Patients with cardiac demand pacemakers.
- Patients who are pregnant.
About this study
Official title: Diabetic Wound Healing and Its Relationship to Vascular Circulation.
Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect nerves, skin and blood vessels. Diabetics with problems in their nerves can lose the sense of touch in their feet (called neuropathy) and so may unknowingly cause damage to the skin resulting in skin loss or an 'ulcer'. Diabetics also have difficulty healing any damaged tissues especially if the patients have diseased blood vessels causing a lack of blood to areas of the body including the feet (called ischaemia).
Read the detailed description
Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect nerves, skin and blood vessels. Diabetics with problems in the patients nerves can lose the sense of touch in the patient's feet (called neuropathy) and so may unknowingly cause damage to the skin resulting in skin loss or an 'ulcer'. Diabetics also have difficulty healing any damaged tissues especially if the patient have diseased blood vessels causing a lack of blood to areas of the body including the feet (called ischaemia). Therefore diabetics have a greater chance of having an ulcer and a higher chance that it does not heal up. The loss of a protective skin barrier means that bacteria can enter the foot causing infections which can spread to bone and beyond. Ultimately this can result in gangrene, amputation or even death.
Stem or progenitor cells help repair and replace damage in the body. Blood vessels are key to this repair. Recent research has suggested that special progenitor cells found in the blood may be responsible. They are called Endothelial Progenitor Cells (EPCs) and seem to be in fewer numbers and are less effective at repair in diabetics.
Current treatments for diabetic wounds are not always successful and so the investigators need more research to look at new treatments. One possibility is to use electrical stimulation of nerves in the leg. Research studies have shown this may improve blood circulation and healing of wounds. This research will assess EPCs to see if they are linked to ulcer healing in diabetic patients with neuropathy only or with ischaemia as well. Furthermore the investigators wish to investigate whether electrical stimulation can affect progenitor cells and wound healing in these patients. The longterm goal of this research is to help diabetic patients improve their quality of life by reducing wound related complications
- Conditions
- Diabetes
- Being tested
- Electrical stimulation device.
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation device.Device
Also called GekoTM Device
In the intervention group, all participants will receive Geko device which will produce electrical stimulation to enhance wound healing. This is the non- invasive device, self adhesive, light and does not restrict the patient's movement. Wound will be measured at the beginning of the study (before the device is applied) and after the study is complete. Blood and wound tissue samples will also be taken pre and post electrical stimulation to observe the effect of electrical stimulation on wound healing in people with diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Diabetic Neuropathy with electrical stimulation device and standard of care. Receives: Device: Electrical stimulation device. |
| Group 2 | No intervention | Diabetic neuropathy with standard of care. |
| Group 3 | Active comparator | Diabetic neuroischemia with electrical stimulation device and standard of care. Receives: Device: Electrical stimulation device. |
| Group 4 | No intervention | Diabetic neuroischemia with standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in ulcer size at monthly intervals up to 12 months follow up.
The wound will be measured after the electrical stimulation produced by Geko device is applied.
Measured: 12 months
Secondary outcomes (1)
Proportion of wounds healed at monthly intervals up to 12 months followup
Percentage of wounds healed after the electrical stimulation produced by Geko device is applied.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, Firstkind Ltd
- Responsible party
- Principal investigator, Ahmad Najib bin Hasan, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378909
- Sponsor's protocol ID
- UManchester
- Acronym
- Geko
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2015
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Wound Healing and Its Relationship to Vascular Circulation.
- ClinicalTrials.gov ID
- NCT02378909
- Acronym / sponsor ID
- Geko / UManchester
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, Firstkind Ltd
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 4 Mar 2015 (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.
Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect nerves, skin and blood vessels. Diabetics with problems in their nerves can lose the sense of touch in their feet (called neuropathy) and so may unknowingly cause damage to the skin resulting in skin loss or an 'ulcer'. Diabetics also have difficulty healing any damaged tissues especially if the patients have diseased blood vessels causing a lack of blood to areas of the body including the feet (called ischaemia).
Detailed description
Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect nerves, skin and blood vessels. Diabetics with problems in the patients nerves can lose the sense of touch in the patient's feet (called neuropathy) and so may unknowingly cause damage to the skin resulting in skin loss or an 'ulcer'. Diabetics also have difficulty healing any damaged tissues especially if the patient have diseased blood vessels causing a lack of blood to areas of the body including the feet (called ischaemia). Therefore diabetics have a greater chance of having an ulcer and a higher chance that it does not heal up. The loss of a protective skin barrier means that bacteria can enter the foot causing infections which can spread to bone and beyond. Ultimately this can result in gangrene, amputation or even death.
Stem or progenitor cells help repair and replace damage in the body. Blood vessels are key to this repair. Recent research has suggested that special progenitor cells found in the blood may be responsible. They are called Endothelial Progenitor Cells (EPCs) and seem to be in fewer numbers and are less effective at repair in diabetics.
Current treatments for diabetic wounds are not always successful and so the investigators need more research to look at new treatments. One possibility is to use electrical stimulation of nerves in the leg. Research studies have shown this may improve blood circulation and healing of wounds. This research will assess EPCs to see if they are linked to ulcer healing in diabetic patients with neuropathy only or with ischaemia as well. Furthermore the investigators wish to investigate whether electrical stimulation can affect progenitor cells and wound healing in these patients. The longterm goal of this research is to help diabetic patients improve their quality of life by reducing wound related complications
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Electrical stimulation device.Diabetic Neuropathy with electrical stimulation device and standard of care. |
| Group 2 | No intervention | –Diabetic neuropathy with standard of care. |
| Group 3 | Active comparator | Device: Electrical stimulation device.Diabetic neuroischemia with electrical stimulation device and standard of care. |
| Group 4 | No intervention | –Diabetic neuroischemia with standard of care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consenting patients with Type 1 or 2 diabetes.
- Male or female, aged 18-85 years.
- Presence of significant neuropathic ulcers.
- Presence of significant neuroischaemic ulcers.
- Patients who are able and willing to follow the protocol requirements.
Key exclusion criteria (5 listed)
- Unreliable, unwilling or unable to comprehend informed consent.
- Patients with recently diagnosed or with suspected deep vein thrombosis (DVT).
- Patients without neuroischaemic/ neuropathic ulcers
- Patients with cardiac demand pacemakers.
- Patients who are pregnant.
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 |
|---|---|---|
| Electrical stimulation device.Also: GekoTM DeviceIn the intervention group, all participants will receive Geko device which will produce electrical stimulation to enhance wound healing. This is the non- invasive device, self adhesive, light and does not restrict the patient's movement. Wound will be measured at the beginning of the study (before the device is applied) and after the study is complete. Blood and wound tissue samples will also be taken pre and post electrical stimulation to observe the effect of electrical stimulation on wound healing in people with diabetes. | Device | Group 1, Group 3 |
Primary outcome
Improvement in ulcer size at monthly intervals up to 12 months follow up.
Time frame: 12 months
The wound will be measured after the electrical stimulation produced by Geko device is applied.
1 secondary outcome
Proportion of wounds healed at monthly intervals up to 12 months followup
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Electrical stimulation device. in people with Diabetes, run by University of Manchester.
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 5 inclusion and 5 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 Mar 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Improvement in ulcer size at monthly intervals up to 12 months follow up. (time frame: 12 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 Mar 2015.