Pilot Study to inform a study of topical and oral treatments for pyoderma gangrenosum patients (STOP-GAP)

Details of the disease

Pyoderma gangrenosum (PG) is a severe, inflammatory, ulcerative disease of the skin.  The presentation varies but typically begins with the rapid evolution of large ulcers in the skin which coalesce and are very painful.  They can be single or multiple and can be very large, mutilating, disfiguring and scarring.

Patients with PG are not able to continue working and have marked impairment of quality of life with severe pain often requiring strong painkillers.  Patients require daily dressings and become high users of health care resources, frequently having to be admitted to hospital.

The proposed research

The purpose of the main multicentre trial is to assess the effects of four commonly used treatments for PG. This pilot study will assess the feasibility of the study design, make sure that we are measuring the right things for patients and to allow us to make links with patients so that they can advise the study team.

This pilot work has the following specific aims:

1. To inform the design of the subsequent randomised controlled trial (RCT).
2. To assess the willingness of clinicians to randomise patients into the study.
3. To involve patients and their carers in the research process at an early stage.
4. To assess the usefulness of using digital images of the skin taken by the participants

Pilot 1

Case Note Review
At centres across the UK, members of the UK DCTN will undertake a review of patient hospital records to see how many have been treated for PG in the last 3 years.  Pilot 1 will assess the characteristics of patients with PG including how and where they were treated and will help us to estimate the number of people who may like to take part in the full study.

Pilot 2

Study Logistics
This part of the pilot study will take place over 6 months. At four recruiting centres, dermatologists will treat PG patients as they would normally. Digital images of an ulcer will be taken at the clinic using a standard method and the patients will then be asked to take digital images of the lesions themselves at home before and after follow up visits. Different types of camera will be tried out to see which are the best and the lesions will be scored by both the clinician and patient using a global assessment score.  The results from pilot study 2 will allow us to test out both the reliability of global assessment and clinical images taken by patients along with the how the patients would feel about taking part in a PG trial.

Pilot 3

Qualitative research
We will use a variety of methods including surveys, questionnaires, focus groups and structured interviews to allow us to take into account the opinions of both patients and carers and medical staff about this study and how it could affect them. This will also help us to set up a panel of patients/carers to help with the set up and running of the full clinical trial.

Funding

The pilot study has been kindly funded by the British Skin Foundation (BSF) and an additional grant has been provided by the UK DCTN, from its pump priming funds.

Contact

If you would like more information about this study or the main Stop Gap trial then contact the Trial Manager by email: stopgap@nottingham.ac.uk