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

ConditionTrauma Wounds
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIsfahan University of Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Injectable Acellular dermal matrix hydrogel
  • Alginate dressing

Treatment groups

130 Participants
are divided into 2 treatment groups