NCT06978569

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

A Randomized, Outcome Assessor-Blinded Clinical Trial Comparing the Efficacy of Acellular Dermal Matrix (ADM) Hydrogel Versus Alginate Dressings in the Treatment of Chronic Traumatic Wounds

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2025-05-18
• Last updated: 2025-05-18

Locations

1 site across 1 country: Iran