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ISRCTN
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ISRCTN88965832
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ClinicalTrials.gov identifier
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Public title
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Extracorporeal Shock Wave Therapy (ESWT) in the management of Decubitus ulceration in complex neurological disabilities
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0204185326
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Study hypothesis
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To assess whether ESWT improve the rate of healing of decubitus ulceration in people with complex neurological disabilities.
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Ethics approval
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Not provided at time of registration
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Study design
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Single blind crossover study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Skin and Connective Tissue Diseases: Decubitus ulceration
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Participants - inclusion criteria
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All patients in the Royal Hospital for Neuro-disability with decubitus ulceration who do not have exclusion criteria will be included in the study irrespective of age, level of disability or diagnosis.
The total number of patients at the Royal Hospital available for the study is expected to be 36.
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Participants - exclusion criteria
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1. Those patients who decline to receive treatment after the treatment has been explained to them
2. Those with bleeding disorders or who are on anticoagulant therapy
3. Decubitus ulceration of the chest wall (theoretical risk of lung damage from ESWT)
4. Decubitus ulceration of elbows and elbow creases (uncommon and difficult to access)
5. Ulceration of the ear (uncommon, difficult to access, risk of damage to brain)
6. Over a tumor site
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Anticipated start date
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01/10/2006
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Anticipated end date
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30/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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36
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Interventions
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The radiographer will be aware of the treatment (ESWT or placebo) and it is likely that the patient may sense some difference between treatments. The Research Nurse carrying out the measurements will be blind to the treatment.
The patient will either receive one dose of Shockwave therapy or placebo each week for four weeks then after two weeks wash out period the other treatment will be delivered, one dose each week for four weeks..
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Primary outcome measure(s)
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The primary outcome will be the area of pressure sore healed by the end of one month period.
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Secondary outcome measure(s)
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1. Time to heal 50%
2. Time to complete healing
3. Site of ulceration
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Sources of funding
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Royal Hospital for Neuro-disability
NHS R&D Support Funding
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20156981
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Contact name
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Prof
Keith
Andrews
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Address
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Institute of Neuropalliative Rehabilitation
Royal Hospital for Neuro-disability
West Hill
Putney
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City/town
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London
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Zip/Postcode
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SW15 3SW
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Country
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United Kingdom
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Tel
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+44 020 8780 4534
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Fax
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+44 020 8780 4503
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Email
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kandrews@rhn.org.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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08/04/2010
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Date ISRCTN assigned
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28/09/2007
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