The QWhet micro current wound stimulator, evaluation of efficacy and side effects

Applying electrical currents for wound healing is not new, al lot of studies
(see literature overview) have been published proving the efficacy of the
therapy. The most promising current type is the 'micro current' because of its
similarity to the natural healing process.

Several companies have such devices already in the market to treat sub-acute
and chronic wounds. Their devices are often bulky and heavy and are complex to
operate. These devices also need a power outlet, so the patient loses mobility
as long as the treatment is given (several hours a day is necessary). The
current is applied by using standard hydrogel electrodes around or outside the
wound. Because the human body is not a perfect conductor it*s not guaranteed
that the current actually will go through the desired wound area and have
therefore less efficiency. Wound care specialists searched therefore ways to to
get the current inside the wound. In many cases by using very moist dressings
and use the conductive hydrogel electrode on top of these moisturized
dressings. The preparation and extra handling of these wound dressings also
creates an higher risk of infection.

The Q-Whet wound stimulator gives a solution to all this: it*s small, light,
portable and battery operated. There is just one activation button and the
software of the device detects automatically whether there is an internal wound
pad or 2 external pads attached. The patient is maximally mobile and wound
therapy can last 24 hours per day. The micro current is theoretically not
noticeable by the patient.

The aim of this study is to assess the effects and side effects of the QWhet
micro current wound stimulation device in up to 78 subjects with a chronic
wound over a continuous period of 28 days.

The collected (coded) data will be used by Q Care to get CE mark for the QWhet.

The QWhet study is a premarket, prospective, single-arm, single-center study.
A maximum of 78 participants with a chronic wound (existing longer than 3
weeks) will be treated with a wound stimulator in the wound (internal wound
pad) for 28 days.
At the start of the study on day 0, a questionnaire, including VAS and EQ5D, is
completed by the study participant and wound nurse, then every 7 days (days 0,
7, 14, 21 and 28).

The intervention consists solely of adding the QWhet stimulator to the standard
wound treatment.

Risks:

INFECTION: low

The internal pad are sterile packed. The specialised wound care nurse is
trained to apply these materials in a sterile fashion. The package of the
Q-Whet wound stimulator contains an elaborate information brochure for the the
wound care nurse. Before start of the study the wound care nurse will also
recieve a training on how to use the device.

The chances of infection caused by the Q-Whet wound stimulator is low.

ALLERGIC REACTION: low

The internal wound pad is a very thin cloth with a conducting layer fo aluminum
oxide. All needed tests on allergic reactions have been done. Up to now, no
allergic reaction has been registered.

Chances on an allergic reaction are low.

ELECTRICAL CURRENT: none/very low

The current used of 200-800 micro Ampere during a period of a maximum duration
of 30 days is provided by a small watch battery. This current is low and
theoretically not detectable by a patient. In comparison the current used in a
TENS muscle stimulator is 15 milli ampere, more than 18 times the current in
the Q-Whet wound stimulator.

Chances on adverse reactions by electrical current are none/very low

HARDWARE Q-WHET WOUND STIMULATOR: low

The hardware of the Q-whet wound stimulator is a small and light plastic box
(7*5*2 cm). This box sticks tot the skin with an adhesive tape or can be
integrated into the bandage around the wound. If an allergic reaction would
occur, the hardware can be shifted to another location on the body.

Chances on an allergic reaction is low.