Thank you for taking the time to read this document and respond to the brief questions that follow.

This questionnaire hopes to gather information that will help design a study looking at the use of novel skin grafts for those with long standing (chronic) venous leg ulcers.

What is chronic venous ulceration?
Chronic venous ulceration (CVU) describes shallow wounds in the ankle area, usually caused by problems with drainage of blood via the veins of the leg. CVU can be painful, causing sleeplessness and difficulty in walking, leading to low mood and negative effects on quality of life. The condition affects 1 out of every 100 individuals, increasing to 4 out of 100 in those over 65 years of age. This is important, as it is expected that increasing numbers of people will develop CVU as the population ages.

How are chronic venous leg ulcers usually treated?
Compression bandaging (tight bandages wrapped around the leg) performed multiple times a week or tight compression stockings are the main types of management. However, ulcers are difficult to treat and, even when they heal, they can return. Skin grafts (taking healthy skin from another area of the patient's body to cover the wound) are an additional method that can help with healing; however, patients can only access this treatment if they are referred to hospital. This is an issue, as we know that the majority of CVU patients are managed by their GPs or community nurse and do not get referred to vascular services. In addition, waiting times for skin grafts can be long, as this requires the patient to be admitted to hospital and have a general anaesthetic in an operating theatre. Because of this, CVU is an expensive condition, costing up to £2 billion every year in England. There is therefore an interest in identifying new, effective and accessible treatments for CVU

What is the novel skin graft?
Recently, studies have tested ‘decellularised dermis’ (DCD) grafts in patients with chronic leg ulcers. DCD grafts are skin from deceased tissue donors within the UK who have chosen to donate their tissue for the benefit of others after death. The tissue has been processed to remove all skin cells, leaving a threadlike net of tissue. Because the cells have been removed, the graft is completely sterile (free from bacteria or other organisms), therefore not posing any risk of rejection or infection when applied to the wound. When applied to an ulcer, this net works as a scaffold, helping cells grow in the wound more quickly and efficiently, promoting healing; importantly, this can be done in the outpatient department, as application of the graft does not need the patient to stay overnight.

DCD has been tested in different kinds of ulcers, including venous and diabetic ones. The studies in CVU have shown promising results in terms of graft safety and positive effects on healing as have the diabetic ones.

What is the study we are proposing?
The proposed project is a large study to see if using a graft in addition to compression bandaging can help ulcers heal faster than just using the bandages alone.  Participants will randomly be allocated to treatment with one of the two options and followed up at 1 year to see how long it will take for the ulcer to heal. In addition, value for money of either procedure will be assessed; information on the percentage of ulcers that will return and the effects of either treatment on daily activities and quality of life will also be recorded.

 It is hoped that this study will help find out whether DCD grafts:
     1. Are useful in patients with CVU by providing better healing rates compared to compression therapy alone.
     2. Provide better value for money than compression therapy. 

* 1. Consent


By typing my name below I agree that I am voluntarily offering my views and I understand that I do not have to take part, can stop at any time and that my comments may be anonymously quoted.

Name:

* 2. Have you ever had a venous leg ulcer?

* 3. Have you had any previously treatment for a leg ulcer including compression bandages?

* 4. Previous Leg ulcer treatment (if applicable)

* 5. Have you ever had a skin graft on your leg (for any reason, including a leg ulcer)?

* 6. Details of skin graft on leg (if applicable)

* 7. In theory if there was a clinical trial that randomly allocated patients to receive the usual treatment of compression bandaging or the usual bandaging plus a skin graft as detailed above, would you consider or would you have considered entering into this trial? Please note you would be able to enter this trial if you have previously had venous surgery and your ulcer had reoccurred.

* 8. Reason/s you would want to or not want to take part in the clinical trial

* 9. Do you have any concerns (including religious beliefs) about accepting a graft that has been developed using the cells from a deceased donor?

* 10. Further details of concerns accepting the graft

* 11. What aspects of your condition or your care are important to you?

* 12. What are the important measure of success of the treatment for you as a patient?

* 13. Please let us know anything you would like us to consider when designing a study about skin grafts for leg ulcers.

* 14. Thank you for taking the time to respond to these questions, your answers are important in helping us shape our clinical study, and ensure patients and the public are involved in the design of the study. If you would be happy for us to contact you in the future to ask questions about this or your experiences with leg ulceration and treatment, please complete the section below. We will not share your contact details with anyone outside our research team.

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