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

NCT ID: NCT06978569

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Trauma Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ADM hudrogel group

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.

Group Type: EXPERIMENTAL

Injectable Acellular dermal matrix hydrogel

Intervention Type: DEVICE

An injectable, sterile acellular dermal matrix (ADM) gel derived from processed biological tissue, designed to promote healing in chronic wounds. The gel is injected directly onto the wound bed following standard debridement and serves as a biocompatible scaffold to support granulation tissue formation, epithelialization, and wound closure. After application, the wound is covered with a standard secondary dressing. Dressing changes are performed every 2 to 3 days or as clinically indicated.

Alginate Dressing Group

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.

Group Type: ACTIVE_COMPARATOR

Alginate dressing

Intervention Type: DEVICE

A sterile, absorbent alginate wound dressing composed of natural polysaccharide fibers derived from seaweed. Following standard debridement, the alginate dressing is applied directly to the wound bed to manage exudate and maintain a moist wound environment conducive to healing. The dressing is covered with a secondary dressing and changed according to the manufacturer's instructions and clinical protocol.

Interventions

Injectable Acellular dermal matrix hydrogel

An injectable, sterile acellular dermal matrix (ADM) gel derived from processed biological tissue, designed to promote healing in chronic wounds. The gel is injected directly onto the wound bed following standard debridement and serves as a biocompatible scaffold to support granulation tissue formation, epithelialization, and wound closure. After application, the wound is covered with a standard secondary dressing. Dressing changes are performed every 2 to 3 days or as clinically indicated.

Intervention Type: DEVICE

Alginate dressing

A sterile, absorbent alginate wound dressing composed of natural polysaccharide fibers derived from seaweed. Following standard debridement, the alginate dressing is applied directly to the wound bed to manage exudate and maintain a moist wound environment conducive to healing. The dressing is covered with a secondary dressing and changed according to the manufacturer's instructions and clinical protocol.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Fateme Abedini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alzahra hospital

Isfahan, , Iran

Countries

Iran

Central Contacts

Seyed MohammadReza Rahavi, PhD

Role: CONTACT

mrahavi@gmail.com

+989123093989

Facility Contacts

Mehdi Rasti, MD, Clinical Fellowship

Role: primary

rasti@med.mui.ac.ir

+989133111659

Other Identifiers

IR.ARI.MUI.REC.1404.054

Identifier Type: -

Identifier Source: org_study_id