Evaluation of the effect of antimicrobial hydrogel compared to standard treatment on foot ulcers

Evaluation the Efficacy of Antimicrobial Wound Hydrogel vs. Standard Care in Lower Leg Hard-to-Heal Wounds: a Double-Blind Randomized Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250523065854N2

Enrollment

Registered

2025-08-28

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hard-to-heal wounds (e.g., diabetic foot ulcers, venous leg ulcers) and prone to infection.. Non-pressure chronic ulcer of lower limb, not elsewhere classified

Interventions

Intervention 1: Intervention group: 30 people with one or more slow-healing leg ulcers that have not healed for more than 30 days. These people will use antimicrobial hydrogel on the wound area for 6

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants must have one or more lower leg hard-to-heal wounds that last more than 30days without healing has been diagnosed. Wounds prone to infection Treatment failure, even with appropriate antibiotic or antimicrobial treatment

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The percent area reduction (PAR) in wound size. Timepoint: Weekly assessments throughout the 6-week treatment period. Method of measurement: Digital planimetry will be used to measure wound surface area. Images of the wound will be taken using the MolecuLight device, and the area will be calculated using software to ensure precise measurement. The PAR is calculated by comparing the initial wound area to the area measured at subsequent visits, with the formula:PAR= ((Initial Area-Current Area)/ Initial Area) ×100.;40% reduction in PAR at the end of the study. Timepoint: Weekly assessments throughout the 6-week treatment period. Method of measurement: Digital planimetry will be used to measure wound surface area. Images of the wound will be taken using the MolecuLight device, and the area will be calculated using software to ensure precise measurement. The PAR is calculated by comparing the initial wound area to the area measured at subsequent visits, with the formula:PAR= ((Initial Area-Current Area)/ Initial Area) ×100.	—

Measure

Time frame

The percent area reduction (PAR) in wound size. Timepoint: Weekly assessments throughout the 6-week treatment period. Method of measurement: Digital planimetry will be used to measure wound surface area. Images of the wound will be taken using the MolecuLight device, and the area will be calculated using software to ensure precise measurement. The PAR is calculated by comparing the initial wound area to the area measured at subsequent visits, with the formula:PAR= ((Initial Area-Current Area)/ Initial Area) ×100.;40% reduction in PAR at the end of the study. Timepoint: Weekly assessments throughout the 6-week treatment period. Method of measurement: Digital planimetry will be used to measure wound surface area. Images of the wound will be taken using the MolecuLight device, and the area will be calculated using software to ensure precise measurement. The PAR is calculated by comparing the initial wound area to the area measured at subsequent visits, with the formula:PAR= ((Initial Area-Current Area)/ Initial Area) ×100.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Najafipour

Tabriz University of Medical Sciences

farzadnajafipour@gmail.com+98 41 3325 0027

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026