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IRCT20080728001031N33 IRCT 2022-07-03 ATI tech pharmed The Safety of Skin Substitute Application for Chronic Diabetic Foot Ulcer The Safety & Feasibility of Bi-Layered Allogeneic Cultured Keratinocyte and Fibroblast Skin Substitute Application for Chronic Diabetic Foot Ulcers: Clinical Trial Phase I 2022-07-23 anticipated 5 Complete https://irct.ir/trial/62720 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Condition 1: Type 1 diabetes mellitus with foot ulcer. Condition 2: Type 2 diabetes mellitus with foot ulcer. Intervention group: Name of substance used: Bi-layered skin substitute. Chemical composition and its concentration: Allogenic cultured keratinocyte and fibroblast cells. The number of 2 million fibroblast cells per square centimeter on type I bovine collagen bed and then 300,000 keratinocyte cells per square centimeter and a total diameter of 44 square centimeters. Frequency of use: 1 or 2 times. Duration of use: 2 weeks. How to use: A skin replacement graft of the same size as the wound is cut by sterile scissors and placed in the wound area after debridement and then covered with a suitable wound dressing. Manufacturer: ATMP Department of Royan Research Institute.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is confidentiality and ethical issues
public Shayan Farzanbakhsh
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Resalat Highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2251 8388 Shayan.farzanb@yahoo.com Royan Institute scientific Ensiyeh Hajizadeh Saffar
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Resalat Highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2233 9942 hajizadeh.ehs@gmail.com Royan Institute Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 18-80 years Both gender Type I or II diabetes ABI ≥ 0.8 HgA1c ≤ 8% Palpable pulse Ulcer university of Texas score=2A Ulcer ≥ 4w presented ulcer >2w under standard care Ulcer on plantar surface of foot Ulcer Size ≥ 2.0 cm2 Ulcer depth ≤ 1cm 18 years 80 years Both Pregnancy Malignancy not in remission for 5 y Severe malnutrition (serum albumin <2.0) Alcohol or drug abuse Random BS ≥ 450 mg/dL Urine ketones Use of corticosteroids, immunosuppressive or cytotoxic agents, Coumadin History of bleeding disorder Positive viral markers (HIV, HBV, HCV, HTLV, CMV) Participation in another study in previous 30 d Conditions compromise ability to complete the study Clinical evidence of infection at the beginning of the treatment phase Evidence of osteomyelitis Evidence of gangrene Charcot deformity Nondiabetic etiology Tunnels or sinus tracts Ulcer >20 cm2 (longest dimension > 5 cm) Elective osseous procedures to the study foot within 30 d before Increased or decreased in size by ≥ 20% in screening period Severe hepatic impairment (LFT ≥ 2 * ULN) or renal impairment (Cr> 2.5 mg/dl) E10.621 E11.621 Type 1 diabetes mellitus with foot ulcer Type 2 diabetes mellitus with foot ulcer Treatment - Other Intervention group: Name of substance used: Bi-layered skin substitute. Chemical composition and its concentration: Allogenic cultured keratinocyte and fibroblast cells. The number of 2 million fibroblast cells per square centimeter on type I bovine collagen bed and then 300,000 keratinocyte cells per square centimeter and a total diameter of 44 square centimeters. Frequency of use: 1 or 2 times. Duration of use: 2 weeks. How to use: A skin replacement graft of the same size as the wound is cut by sterile scissors and placed in the wound area after debridement and then covered with a suitable wound dressing. Manufacturer: ATMP Department of Royan Research Institute. Short-term or long term, systemic or local, severe or mild, and related or unrelated to cell therapy adverse effects. Timepoint: Before the intervention, at the time of intervention, 3, 7, 14, 18, 21, 28 days and 6, 8, 12, 16, 20 and 24 weeks after the intervention. Method of measurement: Physician assessment by physical examination. Ulcer healing rate. Timepoint: 12th week after intervention. Method of measurement: ImageJ software. 50% improvement in wound size. Timepoint: 12th week after intervention. Method of measurement: ImageJ software. Mean rate of wound healing during the first 12 weeks. Timepoint: Days 3, 7, 14, 18, 21 and 28 as well as weeks 6, 8 and 12 after the intervention. Method of measurement: Physician evaluation and solar calendar. The rate of recurrence of the wound at the site of the previous healing. Timepoint: 24th week after the intervention. Method of measurement: Physician evaluation and examination. ATI tech pharmed Approved 2022-06-18 Research ethics committees of Royan institute-Academic center for education, culture and research Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway Tehran Tehran Iran (Islamic Republic of)