Comparative Efficacy of ADM Hydrogel vs. Alginate Dressings in Chronic Trauma Wounds

Not Applicable

Not yet recruiting

• Conditions: Trauma Wounds

• Registration Number: NCT06978569
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-11
• Study First Submitted QC: 2025-05-11
• Last Update Submitted: 2025-05-11
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Study Start: 2025-07
• Primary Completion: 2026-07
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Alzahra hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of