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A Prospective randomised controlled trial of low-frequency ultrasound debridement (LFUD) for lower limb wounds

A Prospective randomised controlled trial of low-frequency ultrasound debridement (LFUD) for adult patients with hard-to-heal lower limb wounds

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000949583
Enrollment
100
Registered
2024-08-05
Start date
2015-03-02
Completion date
2019-12-02
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this pragmatic, prospective randomised study was to assess the benefit of LFUD in helping manage acute and chronic lower limb wounds. Patients were randomly allocated to receive low-frequency ultrasound debridement plus standard care or standard care (SC) and were assessed at weeks 4, 8, 12, 24, and 52. Wound size, length of hospital stay, theatre visit, operative time, and number of treatments were compared between treatment groups.

Interventions

Participants in the treatment group underwent Low frequency Ultrasound Debridement (LFUD). LFUD using the MIST system (Celleration, Inc, Eden Prairie, MN) was carried out by a wound specialist nurse twice weekly for 3 weeks. This procedure is carried out with a wand that produces a low-energy ultrasound-generated mist with saline. This emulsifies dead and dying tissues with microsized gas bubbles. Each LFUD treatment session lasted approximately 45 minutes. The treatment course was repeated if c

Participants in the treatment group underwent Low frequency Ultrasound Debridement (LFUD). LFUD using the MIST system (Celleration, Inc, Eden Prairie, MN) was carried out by a wound specialist nurse twice weekly for 3 weeks. This procedure is carried out with a wand that produces a low-energy ultrasound-generated mist with saline. This emulsifies dead and dying tissues with microsized gas bubbles. Each LFUD treatment session lasted approximately 45 minutes. The treatment course was repeated if clinically indicated by a vascular surgeon. In most cases, LFUD was performed on the ward or in an outpatient clinic. The type of anaesthetic used depended on wound type and level of patient discomfort. This included topical anaesthetic and/or local infiltration, Entonox gas, and regional or general anaesthetic as required. Hydrogel was used as an autolytic agent. Antimicrobial dressings (silver) and/or oral antibiotics were given if clinically indicated. The wound care specialist involved in each session ensured adherence to the debridement protocol and recorded when patients were considered fully healed

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Male and female adults with lower limb wounds requiring debridement.

Exclusion criteria

Participants were excluded if they were not able to attend follow-up, or if a biopsy confirmed skin malignancy or vasculitis.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026