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Hyperbaric oxygen therapy for lower limb burns in diabetic patients

Effect of hyperbaric oxygen on wound healing and scar outcome in diabetic patients with lower limb burns

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000902190
Enrollment
30
Registered
2019-06-27
Start date
2019-09-02
Completion date
2020-09-01
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing. Diabetic lower limb burns are very common - a recent audit performed in our service revealed 35 such injuries over the past 18 months, 75% of which required debridement and skin grafting. It also identified that these patient stay on average 2.5 times longer in hospital than our normal average length of stay. In addition a third require a second operation and due to poor healing 23% proceeded to some form of amputation. Hyperbaric oxygen therapy has been used increasingly to assist with healing of complex and chronic wounds, however robust evidence for its use, particularly in burns, is still lacking. At Fiona Stanley Hospital we have a HBOT unit and are the adult tertiary referral service for burn injuries. We therefore propose to perform a double blind randomised controlled trial looking at diabetic lower limb burns which required debridement and skin grafting. All diabetic patients with deep lower limb burns would be considered for the trial and would have debridement, skin grafting and VAC therapy within 72 hours of presentation to our service. Immediately post-operatively they would be randomised to receive either HBOT post-operatively OR sham HBOT. These treatments would be delivered daily for 2-4 weeks. After the treatment or sham treatment, the patient would receive standard care for all wounds. At 4 weeks the wounds would be assessed by a clinician blinded to treatment to assess the percentage healing of the wound, using a camera to map the area of the healed/unhealed area of wound to form a ratio. At 3, 6 and 12 months the wounds would be assessed for healing, time in dressings, episodes of breakdown, requirements for secondary surgery and QoL

Interventions

This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing and scar outcome. Diabetic patients with lower limb burns who require debridement and skin grafting would be randomised to receive either: HBOT post-operatively OR sham HBOT This treatment of sham treatment would be delivered at Fiona Stanley Hyperbaric medicine department by trained hyperbaric technicians. These treatments would be delivered dai

This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing and scar outcome. Diabetic patients with lower limb burns who require debridement and skin grafting would be randomised to receive either: HBOT post-operatively OR sham HBOT This treatment of sham treatment would be delivered at Fiona Stanley Hyperbaric medicine department by trained hyperbaric technicians. These treatments would be delivered daily for 2-4 weeks. After the treatment or sham treatment, the patient would receive standard care for all wounds.

Sponsors

Fiona Stanley Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

Adults 18+ years of age Burn below knee on one or both legs First presentation with burn on index limb Type I or II diabetes mellitus Able to consent to trial Fluent in verbal and written English

Exclusion criteria

Pregnant or lactating women Patients who fail the pre-hyperbaric treatment ear pressure test for barotrauma and would require tympanostomy tubes (grommets) Patients who would not pass the screening process for standard hyperbaric treatment (those treated with Bleomycin (increases risk of pulmonary fibrosis); patients with current brain tumours or carbon monoxide poisoning (increased risk of oxygen toxicity) or with existing cataracts (can increase progression)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026