Condition category
Skin and Connective Tissue Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
08/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20156981

Publication citations

  1. 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.

Additional files

Editorial Notes