Condition category
Skin and Connective Tissue Diseases
Date applied
11/07/2006
Date assigned
28/07/2006
Last edited
01/02/2010
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

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 measures

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

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

http://www.dbh.nhs.uk/

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17444382

Publication citations

  1. 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.

Additional files

Editorial Notes