Last updated: October 25, 2023
Sponsor: Axio Biosolutions Pvt. Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
MaxioCel
AquaCel Extra
Clinical Study ID
NCT05312762
ABSPL/01/2021
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 / venousulcer / 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
Exclusion Criteria:
- Known allergy/hypersensitivity to the dressing
- Pregnant women
- Underlying or diagnosed with serious diseases or deemed unsuitable for this clinicalstudy by the study's clinician
- Dry wounds
- Being treated with a high dose of steroids or immunosuppressant therapy or systemicantibiotics
- 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
Study Design
Total Participants: 118
Treatment Group(s): 2
Primary Treatment: MaxioCel
Phase:
Study Start date:
April 27, 2022
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Saveetha Medical College Hospital
Chennai, Tamil Nadu 602105
IndiaActive - Recruiting
Hycare Super Speciality Hospital
Chennai, Tamilnadu 600106
IndiaActive - Recruiting
Vijaya hospitals
Chennai,
IndiaActive - Recruiting
Kamineni Hospitals Pvt Ltd
Hyderabad,
IndiaActive - Recruiting
Yalamanchi hospital and research center vijayawada
Vijayawada,
IndiaActive - Recruiting
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