Diabetes Clinical Trial
— GekoOfficial 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).
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Manchester | Central Manchester University Hospitals NHS Foundation Trust, Firstkind Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months | No |
Secondary | 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. | 12 months | No |
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