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

Primary Purpose

Wound

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
MaxioCel
AquaCel Extra
Sponsored by
Axio Biosolutions Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saveetha Medical College HospitalRecruiting
  • Hycare Super Speciality HospitalRecruiting
  • Vijaya hospitalsRecruiting
  • Kamineni Hospitals Pvt LtdRecruiting
  • Yalamanchi hospital and research center vijayawadaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MaxioCel

AquaCel Extra

Arm Description

Microfiber wound dressing

Hydrofiber dressing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain Management
Changes in pain using Numeric Rating Scale (0-10). 0 means no pain, 10 means severe pain/worst possible pain
Exudate Management
Change in Exudate levels will be evaluated. Exudate levels will be evaluated as per below categories: None, Scant, Small, Moderate, Large
Changes in Epithilizing / Granulating Tissues
measured by % change in Epithelizing and granulating tissues
Bates Janesen Wound Assessment Score
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
Scar Management
Vancouver Scar Scale will be used at the final visit to evaluate the scar formation at wound site. Minimum score - 0; Maximum score - 13
Clinician opinion related to dressing
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
Patient opinion related to dressing
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

Full Information

First Posted
March 18, 2022
Last Updated
January 20, 2023
Sponsor
Axio Biosolutions Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05312762
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
March 11, 2023 (Anticipated)
Study Completion Date
March 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axio Biosolutions Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MaxioCel
Arm Type
Experimental
Arm Description
Microfiber wound dressing
Arm Title
AquaCel Extra
Arm Type
Active Comparator
Arm Description
Hydrofiber dressing
Intervention Type
Device
Intervention Name(s)
MaxioCel
Other Intervention Name(s)
Chitosan Wound Dressing
Intervention Description
Microfiber wound dressing
Intervention Type
Device
Intervention Name(s)
AquaCel Extra
Intervention Description
Hydrofiber dressing
Primary Outcome Measure Information:
Title
Wound Area Measurement
Description
Wound area (cm2) to be recorded at baseline and weekly visits to assess % change in wound area.
Time Frame
Week 1, Week 2, Week 3, Week 4
Secondary Outcome Measure Information:
Title
Pain Management
Description
Changes in pain using Numeric Rating Scale (0-10). 0 means no pain, 10 means severe pain/worst possible pain
Time Frame
Week 1, Week 2, Week 3, Week 4
Title
Exudate Management
Description
Change in Exudate levels will be evaluated. Exudate levels will be evaluated as per below categories: None, Scant, Small, Moderate, Large
Time Frame
Week 1, Week 2, Week 3, Week 4
Title
Changes in Epithilizing / Granulating Tissues
Description
measured by % change in Epithelizing and granulating tissues
Time Frame
Week 1, Week 2, Week 3, Week 4
Title
Bates Janesen Wound Assessment Score
Description
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
Time Frame
Week 1, Week 2, Week 3, Week 4
Title
Scar Management
Description
Vancouver Scar Scale will be used at the final visit to evaluate the scar formation at wound site. Minimum score - 0; Maximum score - 13
Time Frame
Week 4
Title
Clinician opinion related to dressing
Description
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
Time Frame
Week 4
Title
Patient opinion related to dressing
Description
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
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shailee Mehta, MSc.
Phone
+919879009940
Email
clinicalstudy@axiobio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shailee Mehta, MSc
Organizational Affiliation
Axio Biosolutions Pvt. Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Saveetha Medical College Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
602105
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gowtham
Facility Name
Hycare Super Speciality Hospital
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600106
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gowtham
Facility Name
Vijaya hospitals
City
Chennai
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Rajkumar
Facility Name
Kamineni Hospitals Pvt Ltd
City
Hyderabad
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satyanarayana
First Name & Middle Initial & Last Name & Degree
Satyanarayana G
Facility Name
Yalamanchi hospital and research center vijayawada
City
Vijayawada
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
9948024196
First Name & Middle Initial & Last Name & Degree
Dr Sadasiva rao Yalamanchi

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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