Wireless Micro Current Stimulation (WMCS) accelerates wound healing in hard-to-heal chronic wounds compared to standard wound care.
ID
Bron
Verkorte titel
Aandoening
English:
- Chronic wound
- Arterial ulcer
- Venous ulcer
- Diabetic ulcer
- Electroceutical
- Electrical stimulation
Dutch:
- Chronische wond
- Arterieel ulcus
- Veneus ulcus
- Diabtisch ulcus
- Electroceuticals
- Elektrische wondstimulatie
Ondersteuning
https://www.bronovo.nl/vrienden-van-bronovo/projecten/onderzoek
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Monthly wound area reduction during the maximum study related treatment of three months
Doel van het onderzoek
Wireless Micro Current Stimulation (WMCS) accelerates wound healing in hard-to-heal chronic wounds compared to standard wound care.
Onderzoeksopzet
- Weekly wound photography (minimum 4 weeks prior)
- Baseline characteristics
- Weekly wound photography (maximum 12 weeks during)
- Follow-up: 1,3 and 6 months
Onderzoeksproduct en/of interventie
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 once weekly standard outpatient wound care. All data prior to the start of (placebo) WMCS treatment will be used as control group data.
Publiek
M.C.H.A. Doomen
VU Medical Centre
Amsterdam 1007 MB
The Netherlands
(+31) 20 444 9800
m.doomen@vumc.nl
Wetenschappelijk
M.C.H.A. Doomen
VU Medical Centre
Amsterdam 1007 MB
The Netherlands
(+31) 20 444 9800
m.doomen@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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 <0.7 or >1.2
- In case of patients with diabetes: toe systolic pressure <50mmHg
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6276 |
| NTR-old | NTR6450 |
| Ander register | NL52982.098.15 : CCMO |