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Search / Trial NCT06978569

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

Launched by ISFAHAN UNIVERSITY OF MEDICAL SCIENCES · May 11, 2025

Trial Information

Current as of September 07, 2025

Not yet recruiting

Keywords

Chronic Wound Acellular Dermal Matrix Adm Wound Size Alginate

ClinConnect Summary

This clinical trial is looking to compare two types of wound treatments for people with chronic trauma wounds—those that have been around for more than 3 weeks. One treatment is made from acellular dermal matrix (ADM) gel, and the other is a standard alginate dressing. Researchers want to find out if the ADM gel can help these wounds heal better and faster than the alginate dressings, and they will be measuring the size of the wounds and overall healing progress over a 12-week period.

To participate in this study, adults aged 18 and older must have chronic wounds on their lower limbs that are between 4 and 20 square centimeters in size and not too deep (less than 9 mm). Participants will be randomly assigned to receive either the ADM gel or the alginate dressing and will need to attend weekly appointments for wound checks and treatment changes. It's important to note that individuals with certain conditions or who are currently pregnant cannot participate. This trial is not yet recruiting participants but aims to provide valuable information about improving wound care.

Gender

ALL

Eligibility criteria

  • 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

About Isfahan University Of Medical Sciences

Isfahan University of Medical Sciences is a leading academic institution in Iran, dedicated to advancing healthcare through innovative research and education. With a strong emphasis on clinical trials, the university plays a critical role in developing new medical treatments and improving patient outcomes. Its research initiatives are supported by a diverse team of professionals, including physicians, scientists, and healthcare practitioners, who collaborate to address pressing health challenges. The university is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring the integrity and reliability of its clinical research endeavors. Through its comprehensive approach, Isfahan University of Medical Sciences aims to contribute significantly to the global medical community and enhance public health.

Locations

Isfahan, , Iran, Islamic Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported