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

Launched by AXIO BIOSOLUTIONS PVT. LTD. · Mar 28, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of two different wound dressings, MaxioCel and Aquacel Extra, for treating chronic wounds that ooze, such as diabetic foot ulcers and venous or arterial ulcers. The study will last for 4 weeks, and researchers are looking to see which dressing helps wounds heal better.

To participate, you must be at least 18 years old and have a wound that has not healed for 1 to 24 months, with a size between 1 and 50 square centimeters. Unfortunately, if you have certain health conditions, allergies to the dressings, or are pregnant, you may not be eligible. If you join the study, you'll receive one of the two dressings and will be monitored throughout the trial to see how your wound responds to the treatment. This is a great opportunity for those with chronic wounds to potentially benefit from new treatment options.

Gender

ALL

Eligibility criteria

• 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