To Evaluate the Efficacy and Safety of MaxioCel Versus Aquacel Extra for the Management of Chronic Wounds

NCT05312762 | Unknown

• 1 other identifier: ABSPL/01/2021
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 5

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

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

• Wound Area Measurement

  Wound area (cm2) to be recorded at baseline and weekly visits to assess % change in wound area.

  Week 1, Week 2, Week 3, Week 4

Secondary Outcomes (7)

• Pain Management

  Week 1, Week 2, Week 3, Week 4

• Exudate Management

  Week 1, Week 2, Week 3, Week 4

• Changes in Epithilizing / Granulating Tissues

  Week 1, Week 2, Week 3, Week 4

• Bates Janesen Wound Assessment Score

  Week 1, Week 2, Week 3, Week 4

• Scar Management

  Week 4

Study Arms (2)

MaxioCel

EXPERIMENTAL

Microfiber wound dressing

Device: MaxioCel

AquaCel Extra

ACTIVE COMPARATOR

Hydrofiber dressing

Device: AquaCel Extra

Interventions

MaxioCel DEVICE

Microfiber wound dressing

Also known as: Chitosan Wound Dressing

MaxioCel

AquaCel Extra DEVICE

Hydrofiber dressing

AquaCel Extra

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Axio Biosolutions Pvt. Ltd.: lead

Study Sites (5)

Hycare Super Speciality Hospital

Chennai, Tamil Nadu, 600106, India

RECRUITING

Saveetha Medical College Hospital

Chennai, Tamil Nadu, 602105, India

RECRUITING

Vijaya hospitals

Chennai, India

RECRUITING

Kamineni Hospitals Pvt Ltd

Hyderabad, India

RECRUITING

Yalamanchi hospital and research center vijayawada

Vijayawada, India

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Shailee Mehta, MSc

  Axio Biosolutions Pvt. Ltd.

  STUDY CHAIR

Central Study Contacts

Shailee Mehta, MSc.

CONTACT

+919879009940; clinicalstudy@axiobio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 5, 2022
• Study Start: April 27, 2022
• Primary Completion: December 11, 2023
• Study Completion: December 31, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5)