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.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/04/041745
- Lead Sponsor
- Axio Biosolutions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage wound area reductionTimepoint: Percentage wound area reduction with in 28 days of treatment
- Secondary Outcome Measures
Name Time Method Pain management <br/ ><br> Exudate management <br/ ><br> Percentage improvement in epithelizing granulating <br/ ><br> tissues <br/ ><br> Bates Jensen wound assessment score <br/ ><br> Scar Management <br/ ><br> Clinician opinion related to dressing <br/ ><br> Patient opinion related to dressing <br/ ><br>Timepoint: 28 days