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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma Wounds
• Intervention / Treatment: Device: Injectable Acellular dermal matrix hydrogel; Device: Alginate dressing

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seyed MohammadReza Rahavi, PhD; Phone Number: +989123093989; Email: mrahavi@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of
    • Alzahra Hospital
    • Contact: Mehdi Rasti, MD, Clinical Fellowship; Phone Number: +989133111659; Email: rasti@med.mui.ac.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound surface area (cm²) at Week 12, adjusted for baseline wound size	Wound surface area is measured as length × width (in cm²) using digital planimetry. Comparison of wound size between groups at Week 12 will be conducted using ANCOVA, adjusting for baseline wound size and relevant covariates.	Week 1 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete wound healing (100% epithelialization)	Number of days from baseline to full wound closure, defined as 100% epithelialization with no drainage.	Weekly up to 12 weeks
Rate of granulation tissue formation	Visual and digital assessment of granulation tissue coverage over time.	Weekly up to 12 weeks
Rate of wound epithelialization	Proportion of wound area covered by new epithelium, assessed at each follow-up visit.	Weekly up to 12 weeks
Incidence of complications (infection, necrosis, bleeding)	Number and type of wound-related adverse events recorded during follow-up.	Up to 12 weeks
Quality of life score at Week 12	Patient-reported quality of life is assessed using the SF-36 questionnaire at baseline and Week 12. Group differences at Week 12 will be analyzed using ANCOVA, adjusting for baseline SF-36 scores.	Weeks 1 and 12

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 11, 2025
• First Submitted That Met QC Criteria: May 11, 2025
• First Posted (Actual): May 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ADM; acellular dermal matrix; chronic wound; wound size; alginate
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: IR.ARI.MUI.REC.1404.054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Access Criteria: Individual participant data (IPD) underlying published results will be available upon reasonable request from qualified researchers with a methodologically sound proposal.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No