Evaluation of the effectiveness of the ozonized herbal (olive) medicine in comparison with standard treatment on healing of Diabetic Foot Ulcer: a randomized single-blind controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20080904001199N10

Enrollment

Registered

2024-11-24

Start date

2024-11-05

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Condition 1: Diabetic Foot Ulcer. Condition 2: Diabetic Foot Ulcer. Type 2 diabetes mellitus with foot ulcer Type 1 diabetes mellitus with foot ulcer

Interventions

Intervention 1: Intervention group: standard treatment + ozonized herbal (olive) medicine. Intervention 2: Control group: standard treatment.

Eligibility

Sex/Gender

All

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with neuropathic or neuroischemic diabetic foot ulcers with infection (including diabetic foot ulcers classified as PEDIS grade 1 or 2 or Dia Wagner grade 1 to 3) Patients aged between 30 and 65 years. Patients with HbA1c levels equal to or lesser than 8.5%.

Exclusion criteria

Exclusion criteria: Lack of willingness to continue participation. Diagnosis of COVID-19. Attending clinic for reasons other than diabetic foot ulcers. Coagulation disorders (due to the potential risk of bleeding and related complications during the debridement process). History of skin allergies.

Design outcomes

Primary

Measure	Time frame
Ulcer type (neuropathic/neuroischemic). Timepoint: At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention. Method of measurement: Ankle –brachial index (ABI).;Ulcer grading (Wagner and PEDIS system). Timepoint: At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention. Method of measurement: Clinical assessment.;Duration of ulcer healing. Timepoint: At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention. Method of measurement: Clinical assessment.;Area of the diabetic foot ulcer. Timepoint: At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention. Method of measurement: Standard ruler.	—

Measure

Time frame

Ulcer type (neuropathic/neuroischemic). Timepoint: At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention. Method of measurement: Ankle –brachial index (ABI).;Ulcer grading (Wagner and PEDIS system). Timepoint: At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention. Method of measurement: Clinical assessment.;Duration of ulcer healing. Timepoint: At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention. Method of measurement: Clinical assessment.;Area of the diabetic foot ulcer. Timepoint: At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention. Method of measurement: Standard ruler.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Amini

Tehran University of Medical Sciences

mramini@tums.ac.ir+98 21 8822 0038

Outcome results

None listed

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