To study the safety and efficacy of ReliDermÂ®DT in patients with chronic diabetic foot ulcer

Reliance Life Sciences PvtLtd0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male or female between 18-80 years of age
•2. Patient with current diagnosis of Type Î? or Î?Î? Diabetes mellitus with controlled blood sugar
•level at the time of application.
•3.Wound that extends through the dermis and into subcutaneous tissue (granulation
•tissue may be present) but without exposure of muscle, tendon, bone or joint capsule
•at the time of application
•4.Patientâ??s ulcer on foot, sole or heel (below ankle)
•5.Patient with not more than one ulcer on the study foot
•6.Ulcer of >=6 weeks duration (ulcers not responding to routine line of treatment i.e non healing ulcer)
•7. Postdebridement ulcer with an area of approximately 6-10 cm2 and depth of >=2 mm.
•8. Patientâ??s wound (after Debridement) free of necrotic debris and exhibits no sign of clinical infection
•9.Patient with adequate peripheral arterial circulation as determined by palpable dorsalis
•pedis or posterior/anterior tibial artery and by Doppler on the study foot.
•10.The subject is willing and is able to read, understand and sign the study specific informed consent form.

•1. Patient ulcer shows evidence of cellulitis, active osteomyelitis or other clinical infection.
•2. Patient?s ulcer has increased or decreased in size by 50% or more during the screening period.
•3. Patient with a known history of any major metabolic disorder like myxedema
•4. Patient receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, coumadin, heparin or is anticipated to receive such agents
•5. Patient has a history of bleeding disorder or clotting disorder
•6. Severe protein malnutrition as evidenced by serum albumin <2.0g/dl
•7. Severe anaemia Hb<7 g/dl
•8. Infection with Human Immunodeficiency Virus (HIV) or Hepatitis B (HbsAg)

发起方

Reliance Life Sciences PvtLtd