Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hydrogel KM40C is an electrically conductive skin adhesive incorporated in the self-adhesive, geko™ XW-3 neuromuscular electrical stimulation (NMES) device. KM40C has been formulated to adhere to the skin giving good electrical contact for the electrodes, be easy to remove without damaging the skin and be non-irritant. KM40C has been tested for safety in humans, however the skin adhesive performance of this improved hydrogel formulation has not been tested on patients receiving geko™ NMES treatment as an adjunct to standard care for wound management.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care with geko™ W3 device | No Intervention | Current geko™ device incorporating hydrogel adhesive designated KM40A | |
| Standard care with geko™ X-W3 | Active Comparator | Next generation geko™ device incorporating new hydrogel adhesive designated KM40C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| geko™ X-W3 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Skin Adhesive Strength of Hydrogel KM40C Compared to That of Hydrogel KM40A | Self reported - how well did the geko™ device stick to the patients leg? Scale 1-5, Lowest score indicates best adhesion. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Reporting of the incidence of adverse events , incidence of serious adverse events, incidence of study treatment related adverse events, and the incidence of device related adverse events | 28 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Therese Targett | Contact | 07340903377 | marie-therese.targett@firstkindmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Agnes Collarte | St Charles Centre for Health & Wellbeing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central London Community Health Care NHS Trust | London | W10 6DZ | United Kingdom | |||
| Norfolk Community Health and Care NHS Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Norwich |
| NR2 3TU |
| United Kingdom |