Evaluation of vibro-pulse in the treatment of cellulitis of the lower limb
| ISRCTN | ISRCTN07508485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07508485 |
| Protocol serial number | 04/24 |
| Sponsor | Doncaster and Bassetlaw NHS Foundation Trust (UK) |
| Funders | Vibrant Medical Ltd (UK), Doncaster and Bassetlaw NHS Foundation Trust (UK) |
- Submission date
- 11/07/2006
- Registration date
- 28/07/2006
- Last edited
- 01/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Sue Johnson
Scientific
Scientific
Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
| Phone | +44 (0)1302 366 666 |
|---|---|
| susan.johnson6@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
The daily amount of erythema/cellulitis and oedema reduction against time up to seven days. |
| Key secondary outcome measure(s) |
Blood tests (white cell count [WCC]) |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Doncaster Royal Infirmary
Doncaster
DN2 5LT
United Kingdom
DN2 5LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2007 | Yes | No |
