None listed
Conditions
Brief summary
Chronic venous leg ulcers are an extremely common and costly problem across the globe. The burden is expected to rise with an ageing population and the growing epidemic of diabetes and obesity. This will increase the therapeutic challenge for treating clinicians. Standard best practice treatment is compression of the lower leg by bandaging to reduce hydrostatic pressure in the leg. Healing rates vary widely and even after two years of compression therapy up to 50% of all chronic VLUs remain unhealed as patient adherence to compression therapy is a continuing challenge, as is best practice management of people with VLUs in the community. Autologous Platelet Gel (APG) together with compression appears to be a promising new intervention for VLU healing. While there is encouraging data from in vitro, animal and clinical studies, strong evidence for its effectiveness from high quality randomised controlled trials is currently lacking. We propose a pilot clinical trial to determine the efficacy, safety and cost-effectiveness of APG gel as an adjunct to compression therapy in healing venous ulcers. We will also assess ulcer recurrence rate of venous ulcers within 3 months of healing.
Interventions
Autologus Platelet Gel applied to target ulcer in addition to standard best practice compression therapy.
Magellan APG kits will be used for the preparation of the APG treatment. A portion of the patient's blood will be placed in the kit that is linked to a centrifuge which will add fibrin and be set to spin the blood to develop the gel. The Wound Clinic Nurse will draw 60 mls of blood from participants to develop the APG (50 mls) and to send to lab for analysis (10 mls). The APG will be prepare
Autologus Platelet Gel applied to target ulcer in addition to standard best practice compression therapy. Magellan APG kits will be used for the preparation of the APG treatment. A portion of the patient's blood will be placed in the kit that is linked to a centrifuge which will add fibrin and be set to spin the blood to develop the gel. The Wound Clinic Nurse will draw 60 mls of blood from participants to develop the APG (50 mls) and to send to lab for analysis (10 mls). The APG will be prepared as per standard operating procedure. The APG will take 20 – 30 minutes to prepare. During this time the participant will remain on a bed in the wound clinic. The gel preparation can either be placed or sprayed on to the VLU depending on depth of wound. The gel will be applied once. All participants will be treated with standard best practice wound dressing and compression therapy. Compression type will be delegated by the clinician after discussion with the patient. Participants will be informed that the compression bandage must not be removed during the treatment period. Compression bandage must not be removed during week one following gel application, One week after gel application, compression will be removed by study nurse; the ulcer assessed and compression replaced once weekly until ulcer healed or until 12 weeks.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants will be aged over 18 years and have a chronic VLU (target ulcer) that has been present for more than 4 weeks with no improvement. Participants must have an ABPI greater than or equal to 0.7 mmHg to exclude significant arterial insufficiency. The eligible target ulcer will have an area greater than or equal to 1 cm2 to less than or equal to 40 cm2 as measured by acetate tracing grid techniques (largest ulcer on limb and separated from other ulcers by at least 1 cm). If more than one leg ulcer is present, the largest ulcer will be treated.
Exclusion criteria
Participants who have severe liver, cardiac or pulmonary disease or known current malignancy will be excluded.
Outcome results
None listed