Healing the Sole: A research project to investigate the effectiveness and benefits of individual homoeopathic treatment and chiropody 'debridement' for adults with chronic verrucas

ISRCTN ISRCTN11683925
DOI https://doi.org/10.1186/ISRCTN11683925
Secondary identifying numbers RDC01630
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
11/04/2016
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
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Toni Douglas-Gooden
Scientific

St. Leonard's Primary Health Centre
National Homoeopath Service
191a Kentish Town Road
London
NW5 2JU
United Kingdom

Phone +44 (0)20 7482 0432/7301 3347
Email tgooden@btconnect.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleHealing the Sole: A research project to investigate the effectiveness and benefits of individual homoeopathic treatment and chiropody 'debridement' for adults with chronic verrucas
Study objectivesThe objective of this research project is to investigate whether 'individual' homeopathic treatment is effective (by effective we mean has the verruca been cured or reduced in size) and beneficial (by beneficial we mean do the people in the study 'feel better in themselves'), compared to using 'Debridement' (the removal of the superficial callous that forms on the surface of the verruca) to individual adult patients with chronic veruccae, within a busy inner-city, multi-cultural foot-health (chiropody) clinic. The study will further investigate the clinical significant findings from the previous nine months of the study, based at St Leonards (funded by the Blackie Foundation). Was the 75% overall improvement in patient's veruccae achieved in the pilot study, attributed to homeopathic remedies or the therapeutic effect of the consultation? Was this improvement due to a combination of 'self-selection' and the 'natural history' of the condition. To find answers to these questions is the reason why this larger randomised trial using the two 'Debridement' active and placebo groups is proposed. This study will aim to provide the NHS and other foot health departments with more data on the treatments of veruccae. Utilising the outcomes from the study, it is hoped that foot health departments may be able to offer a pain free, holistic and more cost effective treatment for verrucae.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSkin and connective tissue diseases: Viral wards
InterventionDebridement vs homeopathic treatment
Intervention typeOther
Primary outcome measure1. The cure or decrease in size of the verrucae (via photographs from a special grid film camera)
2. The quality of life of the patient - do the patients feel better in themselves? (via SF36 life-style questionnaire)
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/1999
Completion date01/01/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/1999
Date of final enrolment01/01/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St. Leonard's Primary Health Centre
London
NW5 2JU
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

11/04/2016: No publications found, verifying study status with principal investigator.