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IRCT20190701044062N9 IRCT 2021-10-11 Tabriz University of Medical Sciences Effect of ANCIL on diabetic foot wounds Effect of ANSIL(Silver nanoparticles) solution on Diabetic foot wounds: A double-blind clinical trial 2021-10-16 anticipated 80 Complete https://irct.ir/trial/56900 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed using simple randomization using GraphPad software and by a secretary who does not interfere with other stages of the investigation. People will be randomly divided into groups A, B, C, D, Blinding description: A solution that has an active ingredient in ANCIL with a solution that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the solution themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the manufacturer company of the solution). The important point is that the patient is told that the solution used for the patient may be medication or medication. Clinicians or outcome assessors and blind patients will be blinded. 3 Diabetic foot ulcers. Intervention 1: Intervention group: 20 patients with diabetic foot ulcer receive50ppm of ANCIL solution twice a day for 28days and bandaged on the wound. ANCIL solution: ASEPE company introduces ANSIL for the treatment and repair of damaged tissues caused by diabetic wounds, bedsores, and injuries caused by severe burns. Various substances are used in the solution, including plant extracts of silymarin, zinc oxide, silver, ascorbic acid, glycerin, alpha tocopherol, retinoids, and phylloquinone. The type of material and their composition determine that it has the greatest effect on wound healing and strengthening. Intervention 2: Intervention group: 20 patients with diabetic foot ulcer receive100ppm of ANCIL solution twice a day for 28days and bandaged on the wound. ANCIL solution: ASEPE company introduces ANSIL for the treatment and repair of damaged tissues caused by diabetic wounds, bedsores, and injuries caused by severe burns. Various substances are used in the solution, including plant extracts of silymarin, zinc oxide, silver, ascorbic acid, glycerin, alpha tocopherol, retinoids, and phylloquinone. The type of material and their composition determine that it has the greatest effect on wound healing and strengthening. Intervention 3: Intervention group: 20 patients with diabetic foot ulcer receive150ppm of ANCIL solution twice a day for 30 days and bandaged on the wound. ANCIL solution: ASEPE company introduces ANSIL for the treatment and repair of damaged tissues caused by diabetic wounds, bedsores, and injuries caused by severe burns. Various substances are used in the solution, including plant extracts of silymarin, zinc oxide, silver, ascorbic acid, glycerin, alpha tocopherol, retinoids, and phylloquinone. The type of material and their composition determine that it has the greatest effect on wound healing and strengthening. Intervention 4: Control group: Treatment of diabetic foot ulcers in 20 patients in a way other than the mentioned method for 28days. Yes - There is a plan to make this available What will be shared: A portion of the data will be shared. When: 2023-2024 To whom: Researchers and academic staffs Conditions: For further studies Where to obtain: Request via email: Khademishima94@gmail.com Shima Khademi How to obtain: Request via email: Khademishima94@gmail.com Shima Khademi Comments:
public Shima Khademi
No1026,East Second floor, Azarabadegan Ave, Third daneshgah Ave, Nasr Town
Tabriz Iran (Islamic Republic of) 5158375751 +98 41 3662 8155 Khademishima94@gmail.com Tabriz University of Medical Sciences scientific Manouchehr Khoshbaten
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 1334 3010 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Diabetic patients taking insulin with diabetic wound Age range 18 to 80 years 18 years 80 years Both Patients with infectious wounds Sensitivity to topical formulations Patients who need surgery for their wounds Z86.31 Personal history of diabetic foot ulcer Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: 20 patients with diabetic foot ulcer receive50ppm of ANCIL solution twice a day for 28days and bandaged on the wound. ANCIL solution: ASEPE company introduces ANSIL for the treatment and repair of damaged tissues caused by diabetic wounds, bedsores, and injuries caused by severe burns. Various substances are used in the solution, including plant extracts of silymarin, zinc oxide, silver, ascorbic acid, glycerin, alpha tocopherol, retinoids, and phylloquinone. The type of material and their composition determine that it has the greatest effect on wound healing and strengthening. Intervention group: 20 patients with diabetic foot ulcer receive100ppm of ANCIL solution twice a day for 28days and bandaged on the wound. ANCIL solution: ASEPE company introduces ANSIL for the treatment and repair of damaged tissues caused by diabetic wounds, bedsores, and injuries caused by severe burns. Various substances are used in the solution, including plant extracts of silymarin, zinc oxide, silver, ascorbic acid, glycerin, alpha tocopherol, retinoids, and phylloquinone. The type of material and their composition determine that it has the greatest effect on wound healing and strengthening. Intervention group: 20 patients with diabetic foot ulcer receive150ppm of ANCIL solution twice a day for 30 days and bandaged on the wound. ANCIL solution: ASEPE company introduces ANSIL for the treatment and repair of damaged tissues caused by diabetic wounds, bedsores, and injuries caused by severe burns. Various substances are used in the solution, including plant extracts of silymarin, zinc oxide, silver, ascorbic acid, glycerin, alpha tocopherol, retinoids, and phylloquinone. The type of material and their composition determine that it has the greatest effect on wound healing and strengthening. Control group: Treatment of diabetic foot ulcers in 20 patients in a way other than the mentioned method for 28days 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. Tabriz University of Medical Sciences Approved 2021-03-15 Ethics committee of Tabriz University of Medic Central Office of Tabriz University of Medical Sciences Tabriz -Golghast St.- Azadi St. Tabriz East Azarbaijan Iran (Islamic Republic of)