A Randomized, Parallel, Multi-center, Double Blind, Double Arm, Comparative, Pilot Study to Evaluate the Efficacy and Safety of Wound Healing Topical Spray in Patients withDiabetic Foot Ulcer

Inzpera Healthsciences Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年5月2日

试验速览

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•1.Male/female of >=18 and <=75 years of age.
•2.Patient who can and willing to provide written Informed Consent.
•3. Patient with a history of type 2 diabetes mellitus 4.
•4.Patient having Random Blood Sugar [RBG] Ë? 250 mg/dL, on standard antidiabetic treatment.
•5. Patient having glycosylated hemoglobin (HbA1c) of less than 12% (based on the existing reports).
•6.Patient with at least ONE but not more than THREE DFU with wound surface area measured between 1 cm2 and 12 cm2 and depth post-debridement between 1cm2 -2cm2 , on the day of randomization (wound surface area measured by greatest length, greatest width).
•7.Patient with ulcer located at or below malleolar region of foot and Superficial ulcer, Ulcer without infection, mild and moderate infection. Stage I-A, II-A or I-B on University of Texas wound classification system.

•1.Patient Ë? 18 or Ë? 75 years of age.
•2. Pregnant and/or nursing woman.
•3. Patient with more than 3 ulcers.
•4. Patient with ulcers measuring wound surface area more than 12 cm2 and depth more than 2cm2.
•5. Patient having severe or poorly controlled Type II diabetes mellitus with severe hyperglycemia (RBG more than 250 mg/dL).
•6. Patient having HbA1c of more than 12%.
•7. Patient with severe ischemia with Ankle-Brachial Index (ABI) <= 0.7.
•8. Patient having progressive weight loss.
•9. Patient having poor nutritional status (S. albumin less than 2.5g /dL).
•10. Patient with ulcer deep into bone and joint or Osteomyelitis or Severe ulcer.

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