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

Wound Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312762
• Other study ID #: ABSPL/01/2021
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Axio Biosolutions Pvt. Ltd.
• Contact: Shailee Mehta, MSc.
• Phone: +919879009940
• Email: clinicalstudy[@]axiobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: December 31, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound
• Wounds and Injuries

Intervention

Device:
• MaxioCel
Microfiber wound dressing
• AquaCel Extra
Hydrofiber dressing

Locations

Country	Name	City	State
India	Hycare Super Speciality Hospital	Chennai	Tamilnadu
India	Saveetha Medical College Hospital	Chennai	Tamil Nadu
India	Vijaya hospitals	Chennai
India	Kamineni Hospitals Pvt Ltd	Hyderabad
India	Yalamanchi hospital and research center vijayawada	Vijayawada

Sponsors (1)

Lead Sponsor	Collaborator
Axio Biosolutions Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Management	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
Secondary	Exudate Management	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
Secondary	Changes in Epithilizing / Granulating Tissues	measured by % change in Epithelizing and granulating tissues	Week 1, Week 2, Week 3, Week 4
Secondary	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	Week 1, Week 2, Week 3, Week 4
Secondary	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	Week 4
Secondary	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	Week 4
Secondary	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	Week 4