Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADM hudrogel group | Experimental | 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. |
|
| Alginate Dressing Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable Acellular dermal matrix hydrogel | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound surface area (cm²) at Week 12, adjusted for baseline wound size | 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. | Week 1 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete wound healing (100% epithelialization) | Number of days from baseline to full wound closure, defined as 100% epithelialization with no drainage. | Weekly up to 12 weeks |
| Rate of granulation tissue formation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyed MohammadReza Rahavi, PhD | Contact | +989123093989 | mrahavi@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alzahra hospital | Isfahan | Iran |
|
Not provided
Not provided
Individual participant data (IPD) underlying published results will be available upon reasonable request from qualified researchers with a methodologically sound proposal.
Not provided
Not provided
Not provided
Not provided
Not provided
In addition to outcome assessors, the data analyst is blinded to the randomization
|
| Alginate dressing | Device | 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. |
|
Visual and digital assessment of granulation tissue coverage over time.
| Weekly up to 12 weeks |
| Rate of wound epithelialization | Proportion of wound area covered by new epithelium, assessed at each follow-up visit. | Weekly up to 12 weeks |
| Incidence of complications (infection, necrosis, bleeding) | Number and type of wound-related adverse events recorded during follow-up. | Up to 12 weeks |
| Quality of life score at Week 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. | Weeks 1 and 12 |