An interventional study of Injectable Acellular dermal matrix hydrogel and Alginate dressing in Trauma Wounds, sponsored by Isfahan University of Medical Sciences. Not yet recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Isfahan University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
Isfahan University of Medical Sciences is the lead sponsor of 150 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Injectable Acellular dermal matrix hydrogel
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.
Device: Alginate dressing
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.
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.
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.
Time frame: Week 1 and 12
Time to complete wound healing (100% epithelialization)
Number of days from baseline to full wound closure, defined as 100% epithelialization with no drainage.
Time frame: Weekly up to 12 weeks
Rate of granulation tissue formation
Visual and digital assessment of granulation tissue coverage over time.
Time frame: Weekly up to 12 weeks
Rate of wound epithelialization
Proportion of wound area covered by new epithelium, assessed at each follow-up visit.
Time frame: Weekly up to 12 weeks
Incidence of complications (infection, necrosis, bleeding)
Number and type of wound-related adverse events recorded during follow-up.
Time frame: 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.
Time frame: Weeks 1 and 12
Plan to share: Yes
Supporting information: Clinical study report, Analytic code
Access criteria: Individual participant data (IPD) underlying published results will be available upon reasonable request from qualified researchers with a methodologically sound proposal.
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Jul 2026, 12 months later.
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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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