Comparing MaxioCel and Aquacel Extra for treating chronic wounds
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
NA · Axio Biosolutions Pvt. Ltd. · NCT05312762
This study is testing whether a new wound dressing called MaxioCel works better than Aquacel Extra for helping people with chronic wounds heal over four weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Axio Biosolutions Pvt. Ltd. (other) |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Chennai, Tamil Nadu and 4 other locations) |
| Trial ID | NCT05312762 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of two wound dressings, MaxioCel and Aquacel Extra, in managing exuding ulcers over a four-week period. MaxioCel is a chitosan-based dressing, while Aquacel Extra contains carboxymethyl cellulose. The trial aims to determine which dressing provides better healing outcomes for patients with chronic wounds. Participants will be monitored for wound healing progress and any adverse effects during the treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with unhealed or non-healing diabetic foot ulcers, venous ulcers, arterial ulcers, or other exuding wounds lasting between 1 to 24 months.
Not a fit: Patients with dry wounds, known allergies to the dressings, or serious underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with chronic wounds, enhancing healing and quality of life.
How similar studies have performed: Previous studies have shown varying success with different wound dressings, but this specific comparison of MaxioCel and Aquacel Extra is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 / 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 Criteria: * 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
Where this trial is running
Chennai, Tamil Nadu and 4 other locations
- Saveetha Medical College Hospital — Chennai, Tamil Nadu, India (RECRUITING)
- Hycare Super Speciality Hospital — Chennai, Tamilnadu, India (RECRUITING)
- Vijaya hospitals — Chennai, India (RECRUITING)
- Kamineni Hospitals Pvt Ltd — Hyderabad, India (RECRUITING)
- Yalamanchi hospital and research center vijayawada — Vijayawada, India (RECRUITING)
Study contacts
- Study coordinator: Shailee Mehta, MSc.
- Email: clinicalstudy@axiobio.com
- Phone: +919879009940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Wound