None listed
Conditions
Brief summary
Low frequency ultrasonic debridement is a new treatment approved for use at Southern Health to treat diabetes related foot ulcers. This project aims to assess if the use of low frequency ultrasonic debridement to treat diabetes related foot ulcers can achieve faster ulcer healing than standard non-surgical sharps debridement. The current research around the use of low frequency ultrasonic debridement to treat diabetes related foot ulcers is positive and suggests that this therapy leads to faster healing and is potentially les painful that other therapies. There is very little evidence comparing low frequency ultrasonic debridement with other ulcer debriding therapies for diabetes related foot ulcers.
Interventions
Low frequency ultrasonic debridement therapy. LFUD delivers a constant flow of saline through which low frequency ultrasound is delivered. The impact of the ultrasound in the saline close to the wound surface (either direct contact or held up to 1cm away) causes: 1. Acoustic streaming (steady current delivered in a fluid medium i.e. sterile saline) 2. Cavitation (imploding ‘gaps’ in the fluid creating micro-shockwaves). In turn, these impacts result in three clinical effects: 1. Debridement 2. B
Low frequency ultrasonic debridement therapy. LFUD delivers a constant flow of saline through which low frequency ultrasound is delivered. The impact of the ultrasound in the saline close to the wound surface (either direct contact or held up to 1cm away) causes: 1. Acoustic streaming (steady current delivered in a fluid medium i.e. sterile saline) 2. Cavitation (imploding ‘gaps’ in the fluid creating micro-shockwaves). In turn, these impacts result in three clinical effects: 1. Debridement 2. Bactericidal effects 3. Wound healing stimulatory effects Whilst low frequency ultrasonic debridement, can also be performed by podiatrists and wound clinical nurse consultants it differs from non-surgical sharps debridement as it is not dependent upon the clinicans skill to determine what tissue should be removed. Treatments are perfromed weekly until the wound is healed. The low frequency of the ultrasound transmitted through the liquid medium (sterile saline solution) selectively debrides the wound base, leaving healthy and viable tissue intact only removing infected and necrotic tissue thus making it safer for patients. Additionally, this treatment is less painful and has additional benefits when compared to non-surgical sharps debridement including that its action is also bactericidal and stimulates the phases of healing. This suggests an acceralated healing time for ulcers. Each treatment session take 60 minutes and includes assessment and treatment. LFUD is utilised for 30 seconds per centimetre square of the wound size, at its widest and longest points. This treatment will be utilised for the first 6 weeks from recruitment and then the ulcer will be reviewed to determine if there is a clinical indication to continue utilising the therapy. If there is the indication to continue the therapy then no changes will be made. If there is no clinical indication to continue the therapy then particpants will receive the control treatment, which is also standard practice, (Non-surgical sharps debridement) and will remain in the study.
Sponsors
Lucia Michailidis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Equal to and greater that 30 years of age - Able to provide informed consent - Wounds greater than 1cm squared in total area - Wounds present for greater than 1 month - Vascular assessment: Palpable pedal pulses OR toe pressure equal to or greater than 45mmHg OR meeting stages 0 (asymptomatic), 1 (mild claudication) and 2 (moderate claudication at 200m) of the Rutherford Classification for peripheral arterial disease - Infected ulcers being appropriately managed - Ulcers meeting The University of Texas wound classification criteria: A1, A2, A3 (wounds of varying depth without infection or ischaemia) and B1, B2, B3 (wounds of varying depth with infection only)
Exclusion criteria
- Participants taking immunosuppressive medication - Known allergies to wound dressing products - Pre-existing ulcer pain preventing either type of debridement - Vascular assessment: meeting stages 3 (severe classification), 4 (rest pain), 5 (ischaemic ulceration not exceeding ulcer of the digits of the foot) and 6 (severe ischaemic ulcers or frank gangrene) of the Rutherford Classification for peripheral arterial disease - Dry gangrenous ulcers - Fungating ulcers - Malignant ulcers - Those meeting the University of Texas Wound Classification Criteria: A0, B0, C0, D0 (pre or post-ulcerative lesion with complete epithelialisation, with or without infection and ischaemia), C1, C2, C3 (wounds with varying depth and ischaemia only), D1, D2, D3, (wounds with varying depth with ischaemia and infection)
Outcome results
None listed