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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Wound surface area (cm²) at Week 12, adjusted for baseline wound size
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
In addition to outcome assessors, the data analyst is blinded to the randomization
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ADM hudrogel group
Participants in this group will receive an acellular dermal matrix (ADM) hydrogel applied directly to the wound bed following standard debridement procedures. After application, the wound will be covered with a standard secondary dressing. Dressing changes will be performed every 2 to 3 days, or as clinically indicated based on wound condition and healing progress.
Intervention: Injectable Acellular dermal matrix hydrogel (Device)
Alginate Dressing Group
Participants in this group will receive an alginate dressing applied directly to the wound bed following debridement. The wound will be managed with dressing changes performed according to the manufacturer's instructions and standard clinical protocol.
Intervention: Alginate dressing (Device)
Outcomes
Primary Outcomes
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
- Time to complete wound healing (100% epithelialization)(Weekly up to 12 weeks)
- Rate of granulation tissue formation(Weekly up to 12 weeks)
- Rate of wound epithelialization(Weekly up to 12 weeks)
- Incidence of complications (infection, necrosis, bleeding)(Up to 12 weeks)
- Quality of life score at Week 12(Weeks 1 and 12)
Investigators
Fateme Abedini
Principal Investigator
Isfahan University of Medical Sciences