No registrations found.
ID
Source
Brief title
Health condition
English:
- Chronic wound
- Arterial ulcer
- Venous ulcer
- Diabetic ulcer
- Electroceutical
- Electrical stimulation
Dutch:
- Chronische wond
- Arterieel ulcus
- Veneus ulcus
- Diabtisch ulcus
- Electroceuticals
- Elektrische wondstimulatie
Sponsors and support
https://www.bronovo.nl/vrienden-van-bronovo/projecten/onderzoek
Intervention
Outcome measures
Primary outcome
Monthly wound area reduction during the maximum study related treatment of three months
Secondary outcome
- Weekly wound area reduction
- Days upon full epithelisation of the wound surface
- Adverse events
Study objective
Wireless Micro Current Stimulation (WMCS) accelerates wound healing in hard-to-heal chronic wounds compared to standard wound care.
Study design
- Weekly wound photography (minimum 4 weeks prior)
- Baseline characteristics
- Weekly wound photography (maximum 12 weeks during)
- Follow-up: 1,3 and 6 months
Intervention
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.
M.C.H.A. Doomen
VU Medical Centre
Amsterdam 1007 MB
The Netherlands
(+31) 20 444 9800
m.doomen@vumc.nl
M.C.H.A. Doomen
VU Medical Centre
Amsterdam 1007 MB
The Netherlands
(+31) 20 444 9800
m.doomen@vumc.nl
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
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6276 |
| NTR-old | NTR6450 |
| Other | NL52982.098.15 : CCMO |