Evaluation of the efficacy and safety of wound healing solution Diperoxochloric Acid in patients with diabetic foot ulcer: - A multicentric, randomized, double blind, double-arm, Active-controlled, comparative, parallel-group phase III Clinical Trial - Nil

Centaur Pharmaceuticals Pvt Ltd0 个研究点目标入组 311 人开始时间: 待定最近更新: 2021年11月24日

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•All the patients willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form, understand the sense of the Clinical Trial and able to come for follow-ups.
•Patients diagnosed with either Type I or II - diabetes mellitus.
•Patients having random blood sugar [RBG] of 250 mg/dL on standard antidiabetic treatment
•Patients having glycosylated hemoglobin of less than 12%.
•Age: 18 years but 75 years. [75 completed years]
•At least 1 but not more than 3 full thickness [i.e. extending into subcutaneous tissue or beyond] ulcer at foot or below malleolus with at least 4 weeks history and ulcer that does not involve bone, tendons, ligaments or muscles and graded as stage I-A, II-A or I-B on University of Texas wound classification system
•Ulcers with wound surface area measured by greatest length, greatest width between 1 cm2 and 16 cm2 post-debridement on the day of randomization.
•Patients with Ankle-Brachial Pressure Index [ABPI] > 0.7

•Patients with more than 3 ulcers
•Patients with ulcers measuring wound surface area more than 16 cm2
•Ulcers caused by venous or arterial insufficiency or electrical or chemical burns
•Ulcers caused by surgery and especially amputation surgery
•Ulcers showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement, osteomyelitis.
•Patients having history of active Charcoat?s foot of the study foot within 6 months of screening
•Patients having severe or poorly controlled diabetes mellitus with severe hyperglycemia (RBG more than 250 mg/dL).
•Patients having glycosylated hemoglobin of more than 12%.
•Patients having progressive weight loss.
•Patients having poor nutritional status (S. albumin less than 2.5g /dL).
•Treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy.
•Other diseases, which can alter the course of diabetic foot ulcer such as connective tissue disease, renal failure (serum creatinine 3mg /dL) liver failure, malignancy.
•Revascularization surgery performed 8 weeks before entry in the study.
•Pregnant or nursing mothers.
•Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
•Patients with Ankle-Brachial Pressure Index [ABPI] less than 0.7

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