Trauma Wounds
Conditions
Keywords
chronic wound, acellular dermal matrix, ADM, wound size, alginate
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.
Interventions
DEVICEInjectable Acellular dermal matrix hydrogel
An 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.
DEVICEAlginate dressing
A 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.
Sponsors
Isfahan University of Medical Sciences
Study design
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
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound surface area (cm²) at Week 12, adjusted for baseline wound size | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to complete wound healing (100% epithelialization) | Weekly up to 12 weeks | Number of days from baseline to full wound closure, defined as 100% epithelialization with no drainage. |
| Rate of granulation tissue formation | Weekly up to 12 weeks | Visual and digital assessment of granulation tissue coverage over time. |
| Rate of wound epithelialization | Weekly up to 12 weeks | Proportion of wound area covered by new epithelium, assessed at each follow-up visit. |
| Incidence of complications (infection, necrosis, bleeding) | Up to 12 weeks | Number and type of wound-related adverse events recorded during follow-up. |
| Quality of life score at Week 12 | Weeks 1 and 12 | Patient-reported quality of life is assessed using the SF-36 questionnaire at baseline and Week 12. Group differences at Week 12 will be analyzed using ANCOVA, adjusting for baseline SF-36 scores. |
Countries
Iran
Contacts
Primary ContactSeyed MohammadReza Rahavi, PhD
Outcome results
None listed