Our aim is to determine whether Wireless Micro Current Stimulation accelerates wound healing in hard-to-heal chronic wounds as compared to standard wound care treatment by conducting a double-blind, placebo controlled trial.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main study parameter will be the monthly wound area reduction during the
maximum study related treatment of twelve weeks.
Secondary outcome
Secondary outcomes are: days upon full epithelisation of the wound surface,
pain reduction, complications compared to contemporary wound therapies, a
monthly Patient Related Outcome Measure and a cost-effectiveness analysis from
a healthcare perspective.
Background summary
Wireless Micro Current Stimulation (WMCS) is a new method within Electric
Stimulation (ES) therapy. It allows contactless wound treatment and stimulates
the healing process through the induction of the natural *current of injury*.
It uses the capacity of nitrogen and oxygen to donate electrons, thereby
surpassing expensive and cumbersome electrodes and devices. This simple
noninvasive technology has had astounding results in recent studies and is
assumed not only to have a huge potential to recalcitrant wounds but also to
treat chronic wounds generally. It could prove to have a transformative effect
on the treatment of chronic with significant cost reduction.
Study objective
Our aim is to determine whether Wireless Micro Current Stimulation accelerates
wound healing in hard-to-heal chronic wounds as compared to standard wound care
treatment by conducting a double-blind, placebo controlled trial.
Study design
This study will be a double-blind, randomized, placebo controlled trial
conducted within Haaglanden MC, The Hague and Erasmus MC, Rotterdam. Patients
that already received 4 weeks of once weekly standard wound care treatment
during outpatient control are randomised for placebo-controlled WMCS treatment
thrice weekly for 45 minutes. The placebo WMCS device is indistinguishable from
the original WMCS device.
Intervention
All subjects will receive (placebo) WMCS treatment thrice weekly for 45 minutes
per session during the maximum study related treatment of twelve weeks while
using the same dressings as received during once weekly standard outpatient
wound care. All data prior to the start of (placebo) WMCS treatment will be
used as control group data.
Study burden and risks
During the start of the therapy patients may report a minimal burning sensation
or itch at the treatment area, but no side effects or complications have been
reported. Pain medication has never been administered within the recent studies
and no change of the surrounding healthy tissue has been observed.
Bronovolaan 5
Den Haag 2597 AX
NL
Bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age of 18 years and older
- Mentally competent
- Ankle-brachial index between 0.7-1.2
- In case of patients with diabetes: toe systolic pressure should be above 50mmHg
- Signed the informed consent form
- Hard-to-heal chronic wound as defined: Wounds existing over six weeks with a biological or physiological reason for stagnation of the healing process, such as diabetic ulcers, arterial or venous ulcers and pressure sores on the lower extremity with failure to achieve the expected wound healing progress with the use of standard outpatient wound care.
Exclusion criteria
- Pregnancy
- (Cardial) Implanted electrical device
- (Skin)malignancy within the therapeutic range.
- Epilepsy
- Overshoot granulation tissue of the wound
- Severe woundinfection
- Any treatment with metal ion-containing wound care products
- Ankle-brachial index <0.7 or >1.2
- In case of patients with diabetes: toe systolic pressure <50mmHg
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL52982.098.15 |