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

Last updated: October 25, 2023
Sponsor: Axio Biosolutions Pvt. Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

MaxioCel

AquaCel Extra

Clinical Study ID

NCT05312762
ABSPL/01/2021
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 / venousulcer / 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

Exclusion Criteria:

  • Known allergy/hypersensitivity to the dressing
  • Pregnant women
  • Underlying or diagnosed with serious diseases or deemed unsuitable for this clinicalstudy by the study's clinician
  • Dry wounds
  • Being treated with a high dose of steroids or immunosuppressant therapy or systemicantibiotics
  • 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

Study Design

Total Participants: 118
Treatment Group(s): 2
Primary Treatment: MaxioCel
Phase:
Study Start date:
April 27, 2022
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Saveetha Medical College Hospital

    Chennai, Tamil Nadu 602105
    India

    Active - Recruiting

  • Hycare Super Speciality Hospital

    Chennai, Tamilnadu 600106
    India

    Active - Recruiting

  • Vijaya hospitals

    Chennai,
    India

    Active - Recruiting

  • Kamineni Hospitals Pvt Ltd

    Hyderabad,
    India

    Active - Recruiting

  • Yalamanchi hospital and research center vijayawada

    Vijayawada,
    India

    Active - Recruiting

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