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Wireless Micro Current Stimulation: adjunctive therapy for acute and chronic wounds * a randomized controlled trial.

Wireless Micro Current Stimulation: adjunctive therapy for acute and chronic wounds * a randomized controlled trial. - Wireless Micro Current Stimulation/WMCS

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41079
Enrollment
450
Registered
2014-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wondzorg Diabetic ulcer pressure sores/decubitus

Interventions

Patients randomised to WMCS will receive treatment thrice weekly for 45 minutes per session. In case of a chronic wound an extra randomisation takes place to vary the treatment algorithm once weekly

Sponsors

Bronovo Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age of 18 years and older Mentally competent Signed the informed consent form Secondary healing surgical wound or chronic wound as defined: o Acute: natural intended closure of a surgical/traumatic wound, for example post-operative pilodinal sinuses, split skin grafts (SSG), second degree burns, dehiscent wounds or contaminated cutting wounds at the E.R. with conventional wound care methods during follow-up. o Chronic: 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 or decubitus

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Our main study parameter will be the monthly wound area reduction during the maximum study related treatment of three months. Secondary outcomes are: days upon full epithelisation of the wound surface, pain reduction, complications compared to contemporary wound therapies, Patient Related Outcome Measure and a cost analysis on nursing costs and dressing.

Secondary

MeasureTime frame
Secondary outcomes are: days upon full epithelisation of the wound surface, pain reduction, complications compared to contemporary wound therapies, Patient Related Outcome Measure and a cost analysis on nursing costs and dressing.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)