Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-12-31
2024-12-31
Brief Summary
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The objective of this trial is to evaluate the skin adhesive performance of hydrogel KM40C during clinical use of the geko™ XW-3 NMES device to determine whether skin adhesion is at least equivalent if not superior to the adhesive hydrogel KM40A incorporated in the self-adhesive geko™ W3 device which is currently in use clinically. Both devices are indicated for use to promote wound healing, the geko™ W3 NMES device is UKCA and CE marked whereas the geko™ X-W3 is UK CA marked only.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Standard care with geko™ W3 device
Current geko™ device incorporating hydrogel adhesive designated KM40A
No interventions assigned to this group
Standard care with geko™ X-W3
Next generation geko™ device incorporating new hydrogel adhesive designated KM40C
geko™ X-W3
The geko™ X-W3 is a next generation self adhesive medical device incorporating a new formulation skin adhesive. It is about the size of a wrist watch which attaches to the side of the knee and when switched on, gentle painless electrical pulses are produced which contract the calf muscles and increase blood flow to the lower leg. The only difference between the currently used geko™ W3 device and the new geko™ XW-3 device is the adhesive used to attach each device to the skin.
Interventions
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geko™ X-W3
The geko™ X-W3 is a next generation self adhesive medical device incorporating a new formulation skin adhesive. It is about the size of a wrist watch which attaches to the side of the knee and when switched on, gentle painless electrical pulses are produced which contract the calf muscles and increase blood flow to the lower leg. The only difference between the currently used geko™ W3 device and the new geko™ XW-3 device is the adhesive used to attach each device to the skin.
Eligibility Criteria
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Inclusion Criteria
2. Patients who have a lower limb ulcer following evaluation by a Tissue Viability Nurse Specialist
3. Intact healthy skin at the site of geko™ device application.
4. Willing and able to give written informed consent
5. Identified to receive geko™ treatment as an adjunct to standard care for wound management.
Exclusion Criteria
2. Use of any other neuro-modulation device.
3. Use of a cardiac pacemaker
4. Current use of TENS in the pelvic region, back or legs
5. Contraindication to geko ™ NMES treatment
6. No response to geko ™ NMES i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting.
7. Participation in any other clinical trial that may interfere with the outcome of either trial.
18 Years
ALL
No
Sponsors
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Firstkind Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Agnes Collarte
Role: PRINCIPAL_INVESTIGATOR
St Charles Centre for Health & Wellbeing
Locations
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Central London Community Health Care NHS Trust
London, , United Kingdom
Norfolk Community Health and Care NHS Trust
Norwich, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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FSK-R&D-002
Identifier Type: -
Identifier Source: org_study_id
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