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

Evaluation of the effectiveness of Hyiodine comparison 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
IRCT20080904001199N8
Enrollment
96
Registered
2023-08-05
Start date
2023-08-23
Completion date
Unknown
Last updated
2024-01-22

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

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

Interventions

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

Sponsors

Nikan Teb Kimia Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime 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 ContactDr. Mohammad Reza Amini

Tehran University of Medical Sciences

mramini@tums.ac.ir+98 21 8822 0037

Outcome results

None listed

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