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
Protocol serial number	RDC01630
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Healing the Sole: A research project to investigate the effectiveness and benefits of individual homoeopathic treatment and chiropody 'debridement' for adults with chronic verrucas
Study objectives	The 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) studied	Skin and connective tissue diseases: Viral wards
Intervention	Debridement vs homeopathic treatment
Intervention type	Other
Primary outcome measure(s)	1. 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)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/1999
Date of final enrolment	01/01/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St. Leonard's Primary Health Centre

London
NW5 2JU
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

Editorial Notes

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