Evaluation of Efficacy and Safety of AHPL/AYTOP/0113 cream in Patients Suffering from Diabetic Foot Ulcer: A randomized, open label, multicentric, interventional, prospective comparative, clinical study. - NI

Ari Healthcare Pvt Ltd R D Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1). Male and female subjects above 30 years of age
•2). Both type I and type II diabetic patients with diabetic foot ulcer
•3). Diabetic patient who is under regular treatment for diabetes and having HbA1C level less than 12
•4) Diabetic Foot Ulcer with less than 2 grade on University Of Texas Classification Of Diabetic Foot
•5) Foot ulcer that has remained open without healing and not shown improvement for more than 3 months
•6) Patients who can make all necessary visits in 90 days period and comply with the study procedures.
•7) Patients willing to participate in clinical trial and who have read understood and signed informed consent form.

•1)Patients with foot gangrene that needs amputation.
•2)Presence of osteomyelitis in affected foot that needs antibiotic therapy during the study.
•3)Patients who prefer to receive the treatment out of the study
•4)Receiving drugs which may interact with the study therapeutic protocol such as glucocorticoids, immunosuppressive and cytotoxic drugs.
•5)Patient having addiction of alcohol or smoking or tobacco chewing
•6)Patients having any major systemic disease other than diabetes such as genetic, endocrinal diseases, hematological disorders, Pulmonary tuberculosis, HIV, AIDS, cancers, congestive heart failure, end stage renal disease and liver failure etc. that may affect the healing of ulcers.
•7)Patient under treatment of diabetic foot ulcers with systemic steroids within three months before study entry.
•8)Pregnant or lactating women
•9)Patients having known hypersensitivity to ingredients used in study drug
•10)Patient with uncontrolled Hypertension, hypothyroidism and hyperthyroidism
•11)Other conditions, which in the opinion of the investigators, make the patient unsuitable for enrollment or could interfere with his her participation in, and completion of the study

发起方

Ari Healthcare Pvt Ltd R D Centre