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Draadloze Elektrostimulatie: een aanvullende behandeling voor recalcitrante chronische wonden - een dubbel-blinde, placebo gecontroleerde studie

Wireless Micro Current Stimulation: adjunctive therapy for hard-to-heal chronic wounds – a double-blind, placebo controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22095
Enrollment
42
Registered
2017-05-15
Start date
2015-09-28
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

English: - Chronic wound - Arterial ulcer - Venous ulcer - Diabetic ulcer - Electroceutical - Electrical stimulation Dutch: - Chronische wond - Arterieel ulcus - Veneus ulcus - Diabtisch ulcus - Electroceuticals - Elektrische wondstimulatie

Interventions

All subjects will receive (placebo) WMCS treatment thrice weekly for 45 minutes per session during the maximum study related treatment of three months while using the same dressings as received during

Sponsors

Department of plastic-, reconstructive- and hand surgery, Haaglanden Medical Centre, The Hague
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age: 18 years and older - Mentally competent - Ankle-brachial index between 0.7-1.2 - In case of diabetes: toe systolic pressure >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

Exclusion criteria: - Pregnancy - (Cardial) Implanted electrical device - (Skin)malignancy within the therapeutic range. - Epilepsy - Overshoot granulation tissue of the wound - Severe woundinfection, need for antibiotics - Any treatment with metal ion-containing wound care products - Ankle-brachial index 1.2 - In case of patients with diabetes: toe systolic pressure <50mmHg

Design outcomes

Primary

MeasureTime frame
Monthly wound area reduction during the maximum study related treatment of three months

Secondary

MeasureTime frame
- Weekly wound area reduction - Days upon full epithelisation of the wound surface - Adverse events

Contacts

Public ContactM.C.H.A. Doomen

Postbus 7057

m.doomen@vumc.nl(+31) 20 444 9800

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)