Contact information
Type
Scientific
Primary contact
Mrs Sue Johnson
ORCID ID
Contact details
Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
+44 (0)1302 366 666
susan.johnson6@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/24
Study information
Scientific title
Acronym
Study hypothesis
To ascertain whether the application of cycloidal vibration (vibro-pulse) would reduce treatment time compared to current standard treatment alone.
Ethics approval
Doncaster Local Research Ethics Committee and Medicines and Healthcare Products Regulatory Agency, dated: 13/03/04 (reference number: 04/24).
Study design
Non-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Lower limb cellulitis (erysipelas)
Intervention
Control group: prescribed antibiotics and bed rest.
Experimental group: prescribed antibiotics, bed rest and cycloidal vibration (vibro-pulse) three times a day for 30 minutes per treatment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The daily amount of erythema/cellulitis and oedema reduction against time up to seven days.
Secondary outcome measures
Blood tests (white cell count [WCC])
Overall trial start date
01/06/2004
Overall trial end date
01/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosed cellulitis (erysipelas) of the lower limb
2. Prescribed treatment of either oral or intravenous antibiotics and bed rest
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Pregnancy
2. Under 18 years old
3. Diagnosed with deep vein thrombosis
4. Non-compliant with medical treatment
Recruitment start date
01/06/2004
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Doncaster Royal Infirmary
Doncaster
DN2 5LT
United Kingdom
Sponsor information
Organisation
Doncaster and Bassetlaw NHS Foundation Trust (UK)
Sponsor details
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
+44 (0) 130 236 6666
susan.johnson6@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Vibrant Medical Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Doncaster and Bassetlaw NHS Foundation Trust (UK)
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17444382
Publication citations
-
Results
Johnson S, Leak K, Singh S, Tan P, Pillay W, Cuschieri RJ, Mostyn E, Can cycloidal vibration plus standard treatment reduce lower limb cellulitis treatment times?, J Wound Care, 2007, 16, 4, 166-169.