Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: MaxioCel: MaxioCel is a soft, sterile, single-use absorbent microfiber wound dressing used for absorption of wound exudate and control of minor bleeding. It transforms into a cohesive g
Sponsors
Axio Biosolutions Pvt Ltd
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage wound area reductionTimepoint: Percentage wound area reduction with in 28 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain management Exudate management Percentage improvement in epithelizing granulating tissues Bates Jensen wound assessment score Scar Management Clinician opinion related to dressing Patient opinion related to dressing Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactShailee Mehta
Axio Biosolutions Pvt Ltd
Outcome results
None listed