Evaluation of vibro-pulse in the treatment of cellulitis of the lower limb

ISRCTN	ISRCTN07508485
DOI	https://doi.org/10.1186/ISRCTN07508485
Secondary identifying numbers	04/24

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Sue Johnson
Scientific

Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom

Phone	+44 (0)1302 366 666
Email	susan.johnson6@nhs.net

Study design	Non-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	To ascertain whether the application of cycloidal vibration (vibro-pulse) would reduce treatment time compared to current standard treatment alone.
Ethics approval(s)	Doncaster Local Research Ethics Committee and Medicines and Healthcare Products Regulatory Agency, dated: 13/03/04 (reference number: 04/24).
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2004
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Key inclusion criteria	1. Diagnosed cellulitis (erysipelas) of the lower limb 2. Prescribed treatment of either oral or intravenous antibiotics and bed rest
Key exclusion criteria	1. Pregnancy 2. Under 18 years old 3. Diagnosed with deep vein thrombosis 4. Non-compliant with medical treatment
Date of first enrolment	01/06/2004
Date of final enrolment	01/01/2006

Doncaster Royal Infirmary

Doncaster
DN2 5LT
United Kingdom

Doncaster and Bassetlaw NHS Foundation Trust (UK)
Hospital/treatment centre

Armthorpe Road
Doncaster
DN2 5LT
England
United Kingdom

Industry

Vibrant Medical Ltd (UK)

No information available

Doncaster and Bassetlaw NHS Foundation Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2007		Yes	No