Effect of ANCIL on diabetic foot wounds
Phase 3
Recruiting
- Conditions
- Z86.31Diabetic foot ulcers.Personal history of diabetic foot ulcer
- Registration Number
- IRCT20190701044062N9
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Diabetic patients taking insulin with diabetic wound
Age range 18 to 80 years
Exclusion Criteria
Patients with infectious wounds
Sensitivity to topical formulations
Patients who need surgery for their wounds
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The severity of a diabetic foot ulcer is measured using the Texas Scoring System. Timepoint: Before the intervention and 7, 14, 21, and 28 days after the intervention. Method of measurement: The severity of diabetic foot ulcers in patients receiving ANCIL and placebo solution before the intervention and on days 7, 14, 21, and 28 after the intervention is measured using the Texas scoring system. Texas scoring system for diabetic foot ulcers to 4 degrees (0 to 3 Grade 1 is classified according to wound depth, infection, and ischemia as Grade 0 before or after the wound has healed, Grade 1 of a superficial wound that has not involved a tendon, capsule, or bone. Grade 2: The wound has penetrated a tendon or capsule. Grade 3: The wound has penetrated the bone or joint. Stage A: clean wound, Stage B: non-infectious and non-ischemic, Stage C: ischemic and non-ischemic, Stage D: Infectious and ischemic wound.
- Secondary Outcome Measures
Name Time Method