Comparison of cleaning of leg ulcers using pads or wound dressings
- Conditions
- eg ulcer, chronic woundSkin and Connective Tissue DiseasesUlcer of lower limb, not elsewhere classified
- Registration Number
- ISRCTN47349949
- Lead Sponsor
- Activa Healthcare Ltd (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 66
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method