Wound Healing Process in Diabetic Neuropathy and Diabetic Neuroischemia (Geko)

March 24, 2015 updated by: Ahmad Najib bin Hasan, University of Manchester

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Diabetic Neuropathy with electrical stimulation device and standard of care.
Device: Electrical stimulation 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.
Other Names:
  • GekoTM Device
No Intervention: Group 2
Diabetic neuropathy with standard of care.
Active Comparator: Group 3
Diabetic neuroischemia with electrical stimulation device and standard of care.
Device: Electrical stimulation 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.
Other Names:
  • GekoTM Device
No Intervention: Group 4
Diabetic neuroischemia with standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of wounds healed at monthly intervals up to 12 months followup
Time Frame: 12 months
Percentage of wounds healed after the electrical stimulation produced by Geko device is applied.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Collaborators

Manchester University NHS Foundation Trust
Firstkind Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • UManchester

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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