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NCT Number: NCT06978569

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

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Key information

Conditions

Trauma Wounds

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Wound surface area (cm²) at Week 12, adjusted for baseline wound size

    Time frame: Week 1 and 12

    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.

Secondary outcomes

  1. Time to complete wound healing (100% epithelialization)

    Time frame: Weekly up to 12 weeks

    Number of days from baseline to full wound closure, defined as 100% epithelialization with no drainage.

  2. Rate of granulation tissue formation

    Time frame: Weekly up to 12 weeks

    Visual and digital assessment of granulation tissue coverage over time.

  3. Rate of wound epithelialization

    Time frame: Weekly up to 12 weeks

    Proportion of wound area covered by new epithelium, assessed at each follow-up visit.

  4. Incidence of complications (infection, necrosis, bleeding)

    Time frame: Up to 12 weeks

    Number and type of wound-related adverse events recorded during follow-up.

  5. Quality of life score at Week 12

    Time frame: Weeks 1 and 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seyed MohammadReza Rahavi, PhD

CONTACT

[email protected]

+989123093989

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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