Efficacy of Platelet-Rich Plasma and Platelet-Rich Fibrin in Diabetic Foot Ulcer- A Randomised, parallel group active comparator trial - NI

Chahat Bansal0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•Age more than 18 years and less than 70years
•Both male and female group
•Documented Diagnoses of Diabetes Mellitus
•Ulcer Characteristics
•Ulcer size more than 0.5cm2 and less than 20cm2
•Ulcer site Plantar surface of foot
•Ulcer duration more than 4 weeks
•UTS Grade 1A 1B 1C,2A 2B or 2C
•Ulcers with absent or mild infection according to IWGDF or IDSA grading
•Palpable dorsalis pedis artery anterior tibial artery and posterior tibial artery or
•ABI more than0.8 or duplex ultrasound with biphasic waveform below the knee and preserved peak systolic velocity
•No planned revascularization procedure or vascular surgery with the last or next 30 days from the day of eligibility screening
•Plantigrade foot
•Subjects and caregivers willing and able to comply with all the study procedures and visits and has reasonable expectations of completing the study
•Informed Consent

•Ulcers with moderate or severe infection according to IWGDF grading requiring active surgical debridement or intravenous antibiotics
•Ulcers of grade 1D 2D 3A 3B 3C or 3D according to University of Texas staging for DFUs
•Ulcers due to underlying Charcot foot
•Ulcer on foot other than plantar surface
•Evidence of osteomyelitis on any part of the limb
•Evidence of gangrene on any part of the affected limb
•Bilateral diabetic foot ulcers
•ankle brachial index less than 0.8 or non-palpable ATA PTA DPA
•haemoglobin less than 10g per dl
•platelet count less than 150000 per dl
•Chronic kidney disease with eGFR less than 30 ml per min per 1.73m2 or Urine albumin creatinine ratio of more than 300 mg per g
•Presence of varicosities or deep vein thrombosis in the affected limb
•immunodeficiency
•coagulopathies
•Active malignancy
•Chronic steroid use or immunosuppressive agents within the last 3 months prior to enrolment
•Participation in another study pertaining to advanced wound closure product
•Use of growth factor therapy autologous platelet-rich plasma gel dermal substitute negative pressure wound therapy within two weeks of study enrolment

发起方

Chahat Bansal