None listed
Conditions
Brief summary
This project aims to identify the relationship between biochemical markers in wound fluid and wound healing in chronic venous leg ulcers being treated with compression therapy. A randomised controlled trial will determine the effect of high level compression on wound fluid composition and wound healing in comparison to low level compression therapy. Identification of biochemical markers directly associated with improved healing will provide important new information for health care professionals on the biological processes underlying wound healing during compression. The overall aim is to gain a better understanding of the wound healing process and to utilise this knowledge to develop improved techniques to increase healing rates of leg ulcers, a significant cause of chronic ill-health for older people.
Interventions
Group 1: Four layer compression bandage system - Profore, applied once per week for the 24 weeks of the study (or until healed, whichever occurs sooner), as per producer's instructions and patient's ankle circumference e.g.
Less than 18cm: 2 or more Orthopaedic wool, 1 crepe, 1 Class 3a bandage, 1 Cohesive bandage;
18-25cm: 1 Orthopaedic wool, 1 Crepe, 1 Class 3a bandage, 1 Cohesive bandage;
25-30cm: 1 Orthopaedic wool, 1 Class 3c, 1 Cohesive bandage;
Greater than 30cm: 1 Orthopaedic wool
Group 1: Four layer compression bandage system - Profore, applied once per week for the 24 weeks of the study (or until healed, whichever occurs sooner), as per producer's instructions and patient's ankle circumference e.g. Less than 18cm: 2 or more Orthopaedic wool, 1 crepe, 1 Class 3a bandage, 1 Cohesive bandage; 18-25cm: 1 Orthopaedic wool, 1 Crepe, 1 Class 3a bandage, 1 Cohesive bandage; 25-30cm: 1 Orthopaedic wool, 1 Class 3c, 1 Cohesive bandage; Greater than 30cm: 1 Orthopaedic wool, 1 Class 3a, 1 Class 3c, 1 Cohesive.
Sponsors
Prof. Helen Edwards
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Clients with leg ulcers of venous aetiology - Ankle Brachial Pressure Index >0.8 and <1.3 - Ulcer size between 1cm2 – 30cm2
Exclusion criteria
- Clients unable to mobilise at all i.e. completely bed or wheelchair bound - Ankle Brachial Pressure Index <0.8 or >1.3 - Presence of clinical signs of infection on admission - Clients with cognitive impairment
Outcome results
None listed