Trauma WoundsNCT06978569
Comparative Efficacy of ADM Hydrogel vs. Alginate Dressings in Chronic Trauma Wounds
A study testing Injectable Acellular dermal matrix hydrogel and Alginate dressing in people with Trauma Wounds, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma Wounds
- What is being tested?
- Injectable Acellular dermal matrix hydrogel and Alginate dressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIran
- Study dates
- Jul 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site
Alzahra hospital
Isfahan
Mehdi Rasti, MD, Clinical Fellowship, +989133111659, rasti@med.mui.ac.ir
About this study
Official title: 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
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:
Read more
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.
- Conditions
- Trauma Wounds
- Being tested
- Injectable Acellular dermal matrix hydrogel, Alginate dressing
- Keywords
- chronic wound, acellular dermal matrix, ADM, wound size, alginate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Acellular dermal matrix hydrogelDevice
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.
Alginate dressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Injectable Acellular dermal matrix hydrogel |
| 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. Receives: Device: Alginate dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 and 12
Secondary outcomes (5)
Time to complete wound healing (100% epithelialization)
Number of days from baseline to full wound closure, defined as 100% epithelialization with no drainage.
Measured: Weekly up to 12 weeks
Rate of granulation tissue formation
Visual and digital assessment of granulation tissue coverage over time.
Measured: Weekly up to 12 weeks
Rate of wound epithelialization
Proportion of wound area covered by new epithelium, assessed at each follow-up visit.
Measured: Weekly up to 12 weeks
Incidence of complications (infection, necrosis, bleeding)
Number and type of wound-related adverse events recorded during follow-up.
Measured: 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.
Measured: Weeks 1 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fateme Abedini, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978569
- Sponsor's protocol ID
- IR.ARI.MUI.REC.1404.054
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06978569
- Acronym / sponsor ID
- IR.ARI.MUI.REC.1404.054
- Conditions
- Trauma Wounds
- Keywords
- chronic wound, acellular dermal matrix, ADM, wound size, alginate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADM hudrogel group | Experimental | Device: Injectable Acellular dermal matrix hydrogelParticipants 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 | Device: Alginate dressingParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injectable Acellular dermal matrix hydrogelAn 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. | Device | ADM hudrogel group |
| Alginate dressingA 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. | Device | Alginate Dressing Group |
Primary outcome
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.
5 secondary outcomes
Time to complete wound healing (100% epithelialization)
Time frame: Weekly up to 12 weeks
Rate of granulation tissue formation
Time frame: Weekly up to 12 weeks
Rate of wound epithelialization
Time frame: Weekly up to 12 weeks
Incidence of complications (infection, necrosis, bleeding)
Time frame: Up to 12 weeks
Quality of life score at Week 12
Time frame: Weeks 1 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable Acellular dermal matrix hydrogel and Alginate dressing in people with Trauma Wounds, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seyed MohammadReza Rahavi, PhD (+989123093989, mrahavi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound surface area (cm²) at Week 12, adjusted for baseline wound size (time frame: Week 1 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.