Contact information
Type
Scientific
Primary contact
Prof Keith Andrews
ORCID ID
Contact details
Institute of Neuropalliative Rehabilitation
Royal Hospital for Neuro-disability
West Hill
Putney
London
SW15 3SW
United Kingdom
+44 020 8780 4534
kandrews@rhn.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0204185326
Study information
Scientific title
Acronym
Study hypothesis
To assess whether ESWT improve the rate of healing of decubitus ulceration in people with complex neurological disabilities.
Ethics approval
Not provided at time of registration
Study design
Single blind crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Skin and Connective Tissue Diseases: Decubitus ulceration
Intervention
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..
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary outcome will be the area of pressure sore healed by the end of one month period.
Secondary outcome measures
1. Time to heal 50%
2. Time to complete healing
3. Site of ulceration
Overall trial start date
01/10/2006
Overall trial end date
30/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
36
Participant exclusion criteria
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
Recruitment start date
01/10/2006
Recruitment end date
30/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Neuropalliative Rehabilitation
London
SW15 3SW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Hospital for Neuro-disability
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20156981
Publication citations
-
Results
Larking AM, Duport S, Clinton M, Hardy M, Andrews K, Randomized control of extracorporeal shock wave therapy versus placebo for chronic decubitus ulceration., Clin Rehabil, 2010, 24, 3, 222-229, doi: 10.1177/0269215509346083.