Leg ulcer, chronic wound Skin and Connective Tissue Diseases Ulcer of lower limb, not elsewhere classified
Conditions
Interventions
Treatment arm:
Debrisoft® (Activa Healthcare) consists of monofilament polyester fibres, the reverse side is coated with polyacrylate.
The product is individually packed and sterile (heat treated). D
Sponsors
Activa Healthcare Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: At least 18 years of age 2. Sex: Males and females (provided they are not pregnant) 3. Patients with a leg ulcer (surface area no larger than 40cm^2) of any aetiology and not older than one year. Leg ulcer at least 50% covered with devitalised tissue that is not fixed dry necrotic tissue or tenacious slough. 4. The patient is able to understand the trial and is willing to give written consent to the trial
Exclusion criteria
Exclusion criteria: 1. Leg ulcer larger than 40cm^2 and older than one year 2. Leg ulcer covered by fixed dry necrotic tissue or tenacious slough 3. Leg ulcer not covered to 50% of its surface area with devitalised tissue (slough) 4. Known allergy to components of the Debrisoft® debrider or wound dressing 5. Use of the debrider is too painful and patient cannot tolerate its mechanical action 6. Malignant wound 7. Recent deep venous thrombosis or venous surgery 8. Progressive neoplastic lesion treated by radiotherapy or chemotherapy 9. Prolonged treatment with immunosuppressive agents or high dose corticosteroids 10. Patients who have participated in this trial previously 11. Patients who have participated in a pharmacological clinical trial within the past six months 12. Patients who are unable to understand the aims and objectives of the trial 13. Patients with a known history of non concordance with medical treatment 14. Females who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the performance of two debridement methods upon 1.1. Changes in the appearance of the wound bed will be based upon quantitative size and colour analysis of photographs taken before debridement and ten 10 minutes after debridement has occurred with these measures repeated weekly for 2 weeks. 1.2. The wound size within 14 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The removal of hyperkeratosis 2. The relative costs of each treatment option 3. Narrative reports from clinical staff and subjects regarding their experience of the two interventions 4. Any pain and discomfort associated with the use of the interventions rated using visual analogue scales | — |
Countries
United Kingdom
Outcome results
None listed