None listed
Conditions
Brief summary
Venous leg ulcers make up the majority of chronic leg wounds. These ulcers cause pain and do not heal in a timely manner. They impact quality of life, cause pain and reduce mobility. Wound dressing and compression therapy are used to heal these ulcers. Yet, blue light therapy shows promise is supporting faster ulcer healing. We will test if adding blue light therapy to standard care improves ulcer healing. This will be compared to standard care alone. The EmoLED device uses blue light therapy to reduce inflammation and the effect of bacteria, which may help wounds to heal.
Interventions
Arm 1 will receive standard wound care twice weekly for four weeks (weeks 1-4) and again in week 6. Standard wound care (once a week at the study site (vascular surgery or aged care facility) with a wound care nurse and once a week with community nursing) will be combined with the intervention which is weekly EmoLED therapy for the first four weeks. In weeks 5, 7, 8, 9, 10 and 11, participants will receive wound care from community nurses twice weekly. Participants in Arm 1 will also receive res
Arm 1 will receive standard wound care twice weekly for four weeks (weeks 1-4) and again in week 6. Standard wound care (once a week at the study site (vascular surgery or aged care facility) with a wound care nurse and once a week with community nursing) will be combined with the intervention which is weekly EmoLED therapy for the first four weeks. In weeks 5, 7, 8, 9, 10 and 11, participants will receive wound care from community nurses twice weekly. Participants in Arm 1 will also receive resources for skin care, wound care, exercise and diet at baseline as part of standard care. The skin care, wound care and exercise brochures are general guidance and standard care within the Vascular One setting. The diet resource provided will be the Australian Guide to Healthy Eating Adult Serves guide. Standard care will take 45 minutes if wounds are on one leg or 1 hour and 15 minutes if bilateral wounds. The EmoLED treatment will take 10 minutes - this will be catered for in the standard care time to ensure there is no addition time taken for the intervention group, reinforcing blinding. The EmoLED™ (Florence, Italy) device delivers photobiomodulation therapy using blue light wavelengths specifically designed for wound care applications. The EmoLED™ therapy will be provided at the study site after wound bed preparation and before wound dressings are applied. It will be conducted by a wound care nurse or a vascular surgeon who are part of the research team. The device parameters are: - Spectral bandwidth: 400-430nm - Power density/irradiance: 120mW/cm2 - Irradiated area: 20cm - Energy density/fluence: 14,4 j/cm2. - Treatment distance: 3-5cm (distance from sensor inside) - Power output: 2,3 W – max emission variation 1% - Time: 120 seconds Adherence will be captured in REDCap which includes study visits as well as community nurse standard wound care details.
Sponsors
Vascular One
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for the study: Adults AND Presence of chronic lower leg venous ulcer (Greater than or equal to 6 weeks duration) with a surface area of less than or equal to 80cm2 OR Presence of chronic lower leg non-venous ulcer associated with oedema or immobility (Greater than or equal to 6 weeks duration) with a surface area of less than or equal to 80cm2 AND Ulcer is not circumferential AND Able to attend the required number of clinic visits for wound dressings AND Can provide written informed consent and complete questionnaires or informed consent and questionnaires can be completed by the legal person responsible As the maximum diameter of the EmoLED treatment beam is 5cm (surface area of 19.6cm2) and chronic ulcers require 120 seconds irradiation per application, the maximum ulcer surface area that can be included is 80cm2, equal to a maximum of four consecutive applications (a total of 8 minutes).
Exclusion criteria
Exclusion criteria for the study: Wound present for less than 6 weeks OR Wound greater than 80cm2 OR Circumferential ulcers OR Malignant ulcers OR Arterial ulcers with Toe Brachial Index (TBI) less than 0.5 or Ankle Brachial Pressure Index (ABPI) less than 0.6 OR Pressure ulcers Use of other advanced therapies such as Negative Pressure Wound Therapy (NPWT), grafting, topical oxygen therapy OR Presence of untreated osteomyelitis, spreading or systemic infection OR Previous treatment with photo biomodulation therapy OR Pregnancy or breastfeeding OR Unable to provide informed consent or complete questionnaires The ulcer cannot be circumferential as the ulcer needs to be photographed to measure the wound using the Wound Genius phone application (imito AG, Zurich Switzerland).
Outcome results
None listed