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Investigating the effect of herbal and animal ointment in diabetic foot ulcer patients

Phase I&II study of clinical trial safety and efficacy assessment of ointment made from extracted Shikonin in Alosa branschnikowi and Pusa capsica in patients with diabetic foot ulcers.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230111057111N1
Enrollment
40
Registered
2023-01-26
Start date
2023-01-31
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Diabetes. Ulcer of lower limb, not elsewhere classified

Interventions

Intervention 1: Intervention group: The intervention group received traditional treatment including washing twice a day with normal saline and keeping the wound clean and dry after that using the plan

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: Having a chronic diabetic foot ulcer on an outpatient basis Age range from 30 to 80 years Having a single wound in the legs and extremities (fingers, soles, heels, on the toes) that has not healed for at least 4 weeks Having a body mass index of 18-35

Exclusion criteria

Exclusion criteria: The presence of a wound with an active infection requires receiving intravenous antibiotics Gangrene requiring amputation Smoking, alcohol and drug addiction Taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents. Having concurrent disease

Design outcomes

Primary

MeasureTime frame
Size of diabetic foot ulcer. Timepoint: Measurement of diabetic foot ulcer at the beginning of the study and then on days 7, 14 and 28. Method of measurement: Based on the examination by specialist and the checklist taken from Fermin Digizaz's research called the scoring checklist system for the healing process of diabetic foot ulcer.;Local infection of diabetic foot ulcer. Timepoint: Investigation of wound infection at the beginning of the study and then on days 7, 14 and 28. Method of measurement: Based on the examination by specialist and the checklist taken from Fermin Digizaz's research called the scoring checklist system for the healing process of diabetic foot ulcer.;Granulation tissue formation. Timepoint: Examination of granulation tissue formation at the beginning of the study and then on days 7, 14 and 28. Method of measurement: Based on the examination by specialist and the checklist taken from Fermin Digizaz's research called the scoring checklist system for the healing process of diabetic foot ulcer.

Secondary

MeasureTime frame
The duration of complete healing of diabetic foot ulcer. Timepoint: At the beginning of the study and then on days 7, 14 ,28 and 60. Method of measurement: Based on the examination of the attending physician.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmin Bakhshizadeh Imcheh

Islamic Azad University

bakhshizadeh.dr@gmail.com+98 45 3342 3240

Outcome results

None listed

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