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

Phase 3

Recruiting

• 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; E10.621; E11.621

• Registration Number: IRCT20080904001199N9
• Lead Sponsor: Akam Darou Deylaman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).