To Evaluate the Efficacy and Safety of MaxioCel Versus Aquacel Extra for the Management of Chronic Wounds

An Open Label, Multicentre, Randomized Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MaxioCel Compared With Aquacel Extra for the Management of Exuding Chronic Wounds

The objective of this study is to evaluate the efficacy and safety of MaxioCel vs Aquacel Extra in the management of exuding ulcers/wounds over a period of 4 weeks

The current study intends to compare the efficacy of the chitosan wound dressing (MaxioCel) with another marketed dressing (Aquacel Extra). MaxioCel is made up of chitosan and Aquacel Extra with carboxymethyl cellulose. Both are polymeric dressings.

Inclusion Criteria:

• Male or female 18 years old or above (till 80 years)
• Patients who are willing to sign the written informed consent
• Clinically diagnosed with an unhealed or non-healing diabetic foot ulcer / venous ulcer / arterial ulcer / other ulcers / wounds, etc.
• Wound duration between 1 to 24 months
• A target wound area between 1 cm2 and 50 cm2
• Exuding wounds / ulcers

Exclusion Criteria:

• Known allergy/hypersensitivity to the dressing
• Pregnant women
• Underlying or diagnosed with serious diseases or deemed unsuitable for this clinical study by the study's clinician
• Dry wounds
• Being treated with a high dose of steroids or immunosuppressant therapy or systemic antibiotics
• Presenting a progressive neoplastic lesion treated with radiotherapy or chemotherapy
• Patients who had Deep Vein Thrombosis in the previous 3 months
• Ulcers with clinical signs of infection or erysipelas of the lower limb or biofilm
• Subjects included in clinical study at present or during the past 30 days
• Clinical suspicion of osteomyelitis