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

October 25, 2023 updated by: Axio Biosolutions Pvt. Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Chennai, India
        • Recruiting
        • Vijaya hospitals
        • Contact:
          • Dr Rajkumar
      • Hyderabad, India
        • Recruiting
        • Kamineni Hospitals Pvt Ltd
        • Contact:
          • Satyanarayana
        • Principal Investigator:
          • Satyanarayana G
      • Vijayawada, India
        • Recruiting
        • Yalamanchi hospital and research center vijayawada
        • Contact:
          • 9948024196
        • Principal Investigator:
          • Dr Sadasiva rao Yalamanchi
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 602105
        • Recruiting
        • Saveetha Medical College Hospital
        • Contact:
          • Gowtham
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600106
        • Recruiting
        • Hycare Super Speciality Hospital
        • Contact:
          • Gowtham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MaxioCel
Microfiber wound dressing
Device: MaxioCel
Microfiber wound dressing
Other Names:
  • Chitosan Wound Dressing
Active Comparator: AquaCel Extra
Hydrofiber dressing
Device: AquaCel Extra
Hydrofiber dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Area Measurement
Time Frame: Week 1, Week 2, Week 3, Week 4
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Management
Time Frame: Week 1, Week 2, Week 3, Week 4
Changes in pain using Numeric Rating Scale (0-10). 0 means no pain, 10 means severe pain/worst possible pain
Week 1, Week 2, Week 3, Week 4
Exudate Management
Time Frame: Week 1, Week 2, Week 3, Week 4

Change in Exudate levels will be evaluated. Exudate levels will be evaluated as per below categories:

None, Scant, Small, Moderate, Large
Week 1, Week 2, Week 3, Week 4
Changes in Epithilizing / Granulating Tissues
Time Frame: Week 1, Week 2, Week 3, Week 4
measured by % change in Epithelizing and granulating tissues
Week 1, Week 2, Week 3, Week 4
Bates Janesen Wound Assessment Score
Time Frame: Week 1, Week 2, Week 3, Week 4
The status of wound as per 13 items mentioned in the Bates-Jensen Wound Assessment Tool will be evaluated. Higher the total score, the more severe the wound status.Minimum score - 13 ; Maximum score - 65
Week 1, Week 2, Week 3, Week 4
Scar Management
Time Frame: Week 4
Vancouver Scar Scale will be used at the final visit to evaluate the scar formation at wound site. Minimum score - 0; Maximum score - 13
Week 4
Clinician opinion related to dressing
Time Frame: Week 4
Dressing usability / use of dressing will be evaluated via questionnaire. The options for rating will be Excellent, Good, Fair, Poor. For few questions, options will be Yes or No
Week 4
Patient opinion related to dressing
Time Frame: Week 4
Patients comfort levels with use of dressing will be evaluated via questionnaire. The options for rating will be Excellent, Good, Fair, Poor. For few questions, options will be Yes or No
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axio Biosolutions Pvt. Ltd.

Investigators

  • Study Chair: Shailee Mehta, MSc, Axio Biosolutions Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Estimated)

December 11, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABSPL/01/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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