Evaluation of Efficacy of SIKADERM Topical Ointment in comparison with Standard Treatment in Enhancing Wound Healing and Managing Infections in Diabetic Foot Ulcers

Evaluation of Efficacy of SIKADERM Topical Ointment in comparison with Standard Treatment in Enhancing Wound Healing and Managing Infections in Diabetic Foot Ulcers: A Double Blinded Randomized Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20080904001199N9

Enrollment

100

Registered

2024-02-15

Start date

2024-03-05

Completion date

Unknown

Last updated

2024-03-06

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 1 diabetes mellitus with foot ulcer Type 2 diabetes mellitus with foot ulcer

Interventions

Intervention 1: Control group: Control group: These patients will receive standard treatment including washing with normal saline, debridement and dressing. Every week, after performing sharp debridem

Eligibility

Sex/Gender

All

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Individuals of age 30 to 65 Patients with diabetic neuropathic and neuroischemic foot ulcers Patients with Wagner Grade 1 and 2 Diabetic Foot Ulcer Patients with PEDIS Grade 1 and 2 Diabetic Foot Ulcer Patient with the hemoglobin A1c less than and equal to 8.5

Exclusion criteria

Exclusion criteria: Patient's unwillingness to cooperate Patients with cutaneous allergies Hospitalization for reasons other than diabetic foot ulcers Suffering from coagulation / vascular diseases

Design outcomes

Primary

Measure	Time frame
The bacterial load on the wound surface. Timepoint: Before the intervention - the second week after the intervention- the fourth week after the intervention. Method of measurement: Microbial culture will be done using swap and agar medium. Bacterial colonies are reported qualitatively and quantitatively.;Wound area. Timepoint: Before the intervention - the first week after the intervention - the second week after the intervention - the third week after the intervention - the fourth week after the intervention. Method of measurement: Using digital calipers and ImageJ software. After washing and debriding the wound to measure the surface of the wound, in addition to photography, a digital caliper is used to calculate the largest length and width of the wound. The depth of the wound is also measured and recorded using a probe.	—

Measure

Time frame

The bacterial load on the wound surface. Timepoint: Before the intervention - the second week after the intervention- the fourth week after the intervention. Method of measurement: Microbial culture will be done using swap and agar medium. Bacterial colonies are reported qualitatively and quantitatively.;Wound area. Timepoint: Before the intervention - the first week after the intervention - the second week after the intervention - the third week after the intervention - the fourth week after the intervention. Method of measurement: Using digital calipers and ImageJ software. After washing and debriding the wound to measure the surface of the wound, in addition to photography, a digital caliper is used to calculate the largest length and width of the wound. The depth of the wound is also measured and recorded using a probe.

—

Secondary

Measure	Time frame
Side effects of treatment. Timepoint: throughout the intervention and the fifth week after the intervention. Method of measurement: There will be phone and in-person reviews. Registration is done in the case report form (CRF).	—

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