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.
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
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.
Parallel
Injectable Acellular dermal matrix hydrogel
DeviceAn 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
DeviceA 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.
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.
Time to complete wound healing (100% epithelialization)
Number of days from baseline to full wound closure, defined as 100% epithelialization with no drainage.
Rate of granulation tissue formation
Visual and digital assessment of granulation tissue coverage over time.
Rate of wound epithelialization
Proportion of wound area covered by new epithelium, assessed at each follow-up visit.
Incidence of complications (infection, necrosis, bleeding)
Number and type of wound-related adverse events recorded during follow-up.
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This trial is not recruiting at the moment. You can still explore other options:
