COARCT: Evaluation of COmpression Therapy in Addition to Regular Cellulitis Therapy (Internal Pilot Phase)
A multicentre, open-label randomised controlled trial comparing the addition of compression therapy to standard care, with standard care alone, in the management of acute leg cellulitis: Internal Pilot Phase
Australian National University
30 participants
Jan 23, 2026
Interventional
Conditions
Summary
Cellulitis is a common bacterial infection of the skin and underlying tissue. Acutely, it causes pain and swelling that significantly hinder daily activities. Longer-term, persistent oedema predisposes patients to recurrent cellulitis, creating a relentless cycle of swelling and infection. Our trial will evaluate whether adding compression therapy to standard antibiotic care at the onset of acute cellulitis can hasten can hasten resolution, avoid complications, minimise antibiotic use, and prevent recurrence. An initial internal pilot will refine procedures and support trial expansion. Our vision is to transform cellulitis management by targeting infection and oedema together, enabling faster recovery, reducing long-term disability, saving healthcare resources, and promoting antibiotic stewardship.
Eligibility
Inclusion Criteria11
- Adult (age greater than or equal to 18 years).
- Admitted to hospital (including admissions to HITH).
- Documented diagnosis of lower leg cellulitis.
- Presents with all three of the following at the infection site:
- a. Erythema (or skin discolouration in darker skin)
- b. Oedema
- c. Tenderness or acute pain.
- Infection originating below the knee.
- At least 75% of erythema is located in the lower leg.
- Area of erythema measures a minimum of 75 cm².
- Able and willing to provide written informed consent.
Exclusion Criteria24
- Bilateral Cellulitis* or cases where the diagnosis of cellulitis is uncertain.
- Receipt of intravenous (IV) antibiotics for more than 48 hours before enrolment.
- Currently using compression therapy regularly on the affected leg.
- Leg size does not fit within garment sizing range
- Compression therapy is contraindicated due to one or more of the following:
- a. Suspected or confirmed severe peripheral arterial disease (ABPI less than or equal to 0.5, toe pressure less than or equal to 30mmHg)
- b. Suspected or confirmed limb ischaemia (based on clinical assessment or imaging)
- c. Severe neuropathy with significant sensory loss
- d. Congestive heart failure, New York Heart Association (NYHA) class III or IV, or decompensated heart failure
- e. History of arterial bypass surgery in the affected leg
- f. Confirmed acute deep vein thrombosis (DVT) in the affected leg.
- The clinician determines compression is unsafe due to patient factors, including:
- a. Patient or carer is unable to safely remove compression if needed
- b. Cognitive impairment affecting the patient’s ability to recognise when compression should be removed
- Specialist wound care required for a wound on the affected leg, including:
- a. Surgical management, drainage or debridement
- b. Negative pressure wound therapy
- c. Compression therapy (as indicated for venous ulcers)
- d. Hyperbaric oxygen therapy
- e. Pressure offloading techniques (e.g. contact casting or custom footwear for diabetic ulcers)
- Presence of an abscess.
- Current or anticipated admission to a critical care setting (e.g., Intensive Care Unit or High Dependency Unit).
- Considered unlikely by the investigator to adhere to the clinical trial protocol due to behavioural, social, or medical reasons.
- Prior participation in this study.
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Interventions
Standard care (antibiotics with or without analgesia, per local treatment guidelines) plus the provision of compression therapy: Compression therapy will be provided to participants by a trial clinicians (nurses, physiotherapists, occupational therapists or physicians) in addition to standard care. Participants will be measured for and prescribed two below knee compression class 1 (15-21 mmHg) compression garments. They will be encouraged to wear one garment on the affected leg immediately following randomisation, or as soon as possible/tolerable, and to continue wearing the stockings for one month, rotating the two garments every 1-2 days to allow for washing. Days 0 (day of randomisation) to 14: Participants will be encouraged to wear the stocking 23hrs per day, with a short break for showering and performing skin care. Participants will also be encouraged to moisturise intact skin regularly (1-2 times per day), and to reposition the garment at least 1-2 x per day, or as required for comfort. Day 14 to 28: Participants will be recommended to wear their stocking for at least 8 hours per day, with 24-hour wear being preferable. They will be advised that wearing the stocking during waking hours is likely more beneficial, but wearing it overnight is also acceptable if that is more convenient for them.
Locations(2)
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ACTRN12625001371482