Status:
UNKNOWN
To Evaluate the Efficacy and Safety of MaxioCel Versus Aquacel Extra for the Management of Chronic Wounds
Lead Sponsor:
Axio Biosolutions Pvt. Ltd.
Conditions:
Wound
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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
Detailed Description
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 carbo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT05312762
Start Date
April 27 2022
End Date
December 31 2023
Last Update
October 26 2023
Active Locations (5)
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1
Hycare Super Speciality Hospital
Chennai, Tamil Nadu, India, 600106
2
Saveetha Medical College Hospital
Chennai, Tamil Nadu, India, 602105
3
Vijaya hospitals
Chennai, India
4
Kamineni Hospitals Pvt Ltd
Hyderabad, India