Determining the effectiveness of Hyiodine comparison standard treatment on healing of Diabetic Foot Ulcer

Phase 3

Recruiting

• Conditions: Condition 1: Diabetic Foot Ulcers. Condition 2: Diabetic Foot Ulcers.; Type 1 diabetes mellitus with foot ulcer; Type 2 diabetes mellitus with foot ulcer; E10.621; E11.621

• Registration Number: IRCT20080904001199N8
• Lead Sponsor: ikan Teb Kimia Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Patients with diabetic neuropathic and neuroischemic foot ulcers
Patients with PEDIS Grade 1 and 2 Diabetic Foot Ulcer
Patients with Wagner Grade 1 and 2 Diabetic Foot Ulcer
Patient with the hemoglobin A1c less than and equal to 8.5

Exclusion Criteria

Getting infected with Covid-19
have skin allergies
have thyroid disease
have coagulation disorders

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.

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).