Comparative Efficacy of ADM Hydrogel vs. Alginate Dressings in Chronic Trauma Wounds

Isfahan University of Medical Sciences

Status: Not yet enrolling

Conditions: Trauma Wounds

Treatments: Device: Injectable Acellular dermal matrix hydrogel; Device: Alginate dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT06978569

IR.ARI.MUI.REC.1404.054

Details and patient eligibility

About

The goal of this clinical trial is to find out whether a wound treatment made from acellular dermal matrix (ADM) gel can help heal chronic traumatic wounds more effectively than standard alginate dressings in adults aged 18 and older with wounds that have lasted more than 3 weeks.

The main questions it aims to answer are:

Does ADM gel reduce the size of chronic wounds more than alginate dressings after 12 weeks?

Does ADM gel help wounds heal faster and improve quality of life for patients?

Researchers will compare ADM gel to alginate dressings to see if the ADM gel leads to better healing results and fewer complications.

Participants will:

Be randomly assigned to receive either ADM gel or alginate dressing.

Have the treatment applied directly to their cleaned wound.

Attend weekly visits for up to 12 weeks for wound checks, measurements, and dressing changes.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic trauma wounds persisting ≥3 weeks.
• Wound size between 4 and 20 cm² and depth ≤9 mm on the lower limbs.
• Willingness and ability to provide informed consent.
• Wounds without uncontrolled infection

Exclusion criteria

• Wounds with exposed bone.
• Current use of immunomodulators, corticosteroids, immunosuppressive or cytotoxic drugs.
• Pregnant individuals.
• Significant reduction (≥30%) of wound size during a 2-week run-in phase.
• Concurrent participation in another clinical trial involving drugs.
• Wounds with uncontrolled infection
• Allergy or hypersensitivity to components of ADM gel or alginate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

ADM hudrogel group

Experimental group

Description:

Participants in this group will receive an acellular dermal matrix (ADM) hydrogel applied directly to the wound bed following standard debridement procedures. After application, the wound will be covered with a standard secondary dressing. Dressing changes will be performed every 2 to 3 days, or as clinically indicated based on wound condition and healing progress.

Treatment:

Device: Injectable Acellular dermal matrix hydrogel

Alginate Dressing Group

Active Comparator group

Description:

Participants in this group will receive an alginate dressing applied directly to the wound bed following debridement. The wound will be managed with dressing changes performed according to the manufacturer's instructions and standard clinical protocol.

Treatment:

Device: Alginate dressing