Condition category
Skin and Connective Tissue Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/04/2016
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

Mr Toni Douglas-Gooden

ORCID ID

Contact details

St. Leonard's Primary Health Centre
National Homoeopath Service
191a Kentish Town Road
London
NW5 2JU
United Kingdom
+44 (0)20 7482 0432/7301 3347
tgooden@btconnect.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC01630

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Skin and connective tissue diseases: Viral wards

Intervention

Debridement vs homeopathic treatment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/1999

Overall trial end date

01/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/1999

Recruitment end date

01/01/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (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

Publication citations

Additional files

Editorial Notes

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