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

NCT06978569 | Not Yet Recruiting

• 1 other identifier: IR.ARI.MUI.REC.1404.054
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

chronic wound; acellular dermal matrix; ADM; wound size; alginate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to complete wound healing (100% epithelialization)

  Weekly up to 12 weeks

• Rate of granulation tissue formation

  Weekly up to 12 weeks

• Rate of wound epithelialization

  Weekly up to 12 weeks

• Incidence of complications (infection, necrosis, bleeding)

  Up to 12 weeks

• Quality of life score at Week 12

  Weeks 1 and 12

Study Arms (2)

ADM hudrogel group

EXPERIMENTAL

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

Alginate Dressing Group

ACTIVE COMPARATOR

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

Interventions

Injectable Acellular dermal matrix hydrogel 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.

ADM hudrogel group

Alginate dressing 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.

Alginate Dressing Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Alzahra hospital

Isfahan, Iran

Location

Central Study Contacts

Seyed MohammadReza Rahavi, PhD

CONTACT

+989123093989; mrahavi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In addition to outcome assessors, the data analyst is blinded to the randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Access Criteria: Individual participant data (IPD) underlying published results will be available upon reasonable request from qualified researchers with a methodologically sound proposal.

Locations

IR (1)