Wound Healing Process in Diabetic Neuropathy and Diabetic Neuroischemia

NCT02378909 | Unknown Phase 1 DMC

• 1 other identifier: UManchester
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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'. 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).

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Proportion of wounds healed at monthly intervals up to 12 months followup

  12 months

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Diabetic Neuropathy with electrical stimulation device and standard of care.

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.

Device: Electrical stimulation device.

Group 4

NO INTERVENTION

Diabetic neuroischemia with standard of care.

Interventions

Electrical stimulation device. 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.

Also known as: GekoTM Device

Group 1; Group 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• Manchester University NHS Foundation Trust: collaborator
• Firstkind Ltd: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 4, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 26, 2015

Record last verified: 2015-03