Clinical trial NCT05312762: To Evaluate the Efficacy and Safety of MaxioCel Versus Aquacel Extra for the Management of Chronic Wounds
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound
Lead sponsor: Axio Biosolutions Pvt. Ltd.
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of MaxioCel vs Aquacel Extra in the management of exuding ulcers/wounds over a period of 4 weeks

Detailed description: The current study intends to compare the efficacy of the chitosan wound dressing (MaxioCel) with another marketed dressing (Aquacel Extra). MaxioCel is made up of chitosan and Aquacel Extra with carboxymethyl cellulose. Both are polymeric dressings.

Eligibility 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

Primary outcomes:
measure: Wound Area Measurement
timeFrame: Week 1, Week 2, Week 3, Week 4
Secondary outcomes:
measure: Pain Management
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Exudate Management
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Changes in Epithilizing / Granulating Tissues
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Bates Janesen Wound Assessment Score
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Scar Management
timeFrame: Week 4
measure: Clinician opinion related to dressing
timeFrame: Week 4
measure: Patient opinion related to dressing
timeFrame: Week 4
Other outcomes:
Locations:
city: Chennai
country: India
facility: Saveetha Medical College Hospital
state: Tamil Nadu
city: Chennai
country: India
facility: Hycare Super Speciality Hospital
state: Tamilnadu
city: Chennai
country: India
facility: Vijaya hospitals
city: Hyderabad
country: India
facility: Kamineni Hospitals Pvt Ltd
city: Vijayawada
country: India
facility: Yalamanchi hospital and research center vijayawada
Study officials:
affiliation: Axio Biosolutions Pvt. Ltd.
name: Shailee Mehta, MSc
role: STUDY_CHAIR
References: