search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number27212
- NTR NumberNTR6450
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mei-2017
- Secondary IDsCCMO NL52982.098.15
- Public TitleDraadloze Elektrostimulatie: een aanvullende behandeling voor recalcitrante chronische wonden - een dubbel-blinde, placebo gecontroleerde studie
- Scientific TitleWireless Micro Current Stimulation: adjunctive therapy for hard-to-heal chronic wounds a double-blind, placebo controlled trial
- ACRONYMPlacebo-WMCS
- hypothesisWireless Micro Current Stimulation (WMCS) accelerates wound healing in hard-to-heal chronic wounds compared to standard wound care.
- Healt Condition(s) or Problem(s) studiedChronic wound, Ulcers, Electrical stimulation
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-sep-2015
- planned closingdate1-okt-2017
- Target number of participants42
- InterventionsAll 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.
- Primary outcomeMonthly 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
- Timepoints- Weekly wound photography (minimum 4 weeks prior)
- Baseline characteristics
- Weekly wound photography (maximum 12 weeks during)
- Follow-up: 1,3 and 6 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD M.C.H.A. Doomen
- CONTACT for SCIENTIFIC QUERIESMD M.C.H.A. Doomen
- Sponsor/Initiator Haaglanden Medical Centre, Department of plastic-, reconstructive- and hand surgery
- Funding
(Source(s) of Monetary or Material Support)
Bronovo Research Fund
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD15-mei-2017 - 30-jun-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl