CTRI/2022/04/041745
Completed
Phase 4
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.
Axio Biosolutions Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: O- Medical and Surgical
- Sponsor
- Axio Biosolutions Pvt Ltd
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Male or female 18 years old or above
- •2\) Patients who are willing to sign the written informed consent
- •3\) Clinically diagnosed with an unhealed or non\-healing diabetic foot
- •ulcer / venous ulcer / arterial ulcer / other ulcers / wounds, etc.
- •4\) Wound duration between 1 to 24 months
- •5\) A target wound area between 1 cm2 and 50 cm2
- •6\) Exuding wounds / ulcers
Exclusion Criteria
- •1\) Known allergy/hypersensitivity to the dressing
- •2\) Pregnant women
- •3\) Underlying or diagnosed with serious diseases or deemed unsuitable for this clinical study by the study’s clinician
- •4\) Dry wounds
- •5\) Being treated with a high dose of steroids or immunosuppressant therapy or systemic antibiotics
- •6\) Presenting a progressive neoplastic lesion treated with radiotherapy or chemotherapy
- •7\) Patients who had Deep Vein Thrombosis in the previous 3 months
- •8\) Ulcers with clinical signs of infection or erysipelas of the lower limb or biofilm
- •9\) Subjects included in clinical study at present or during the past 30 days
- •10\) Clinical suspicion of osteomyelitis
Outcomes
Primary Outcomes
Not specified
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