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Wound Healing Process in Diabetic Neuropathy and Diabetic Neuroischemia

NCT02378909 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • Firstkind Ltd

    collaborator INDUSTRY

  • University of Manchester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02378909 on ClinicalTrials.gov