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

NCT06978569 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-05-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Isfahan University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-07-31
Completion
2026-09-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978569 on ClinicalTrials.gov