Status:
NOT_YET_RECRUITING
Comparative Efficacy of ADM Hydrogel vs. Alginate Dressings in Chronic Trauma Wounds
Lead Sponsor:
Isfahan University of Medical Sciences
Conditions:
Trauma Wounds
Eligibility:
All Genders
18-65 years
Phase:
NA
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 dres...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06978569
Start Date
July 1 2025
End Date
September 1 2026
Last Update
May 18 2025
Active Locations (1)
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1
Alzahra hospital
Isfahan, Iran