Randomized, Multi Centric, Comparative, Blinded, Parallel Group,Prospective Study, To Determine Clinical Efficacy and Safety ofTheruptor Sterile Barrier Wound Dressing Of CareNow In ComparisonWith Bactigras of Smith & Nephew and Allevyn of Smith & Nephew on Wound Healing In Patients With Chronic Infected Wounds

CareNow Medical Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1.Male or female of age 18 years or older.
•2.Patients wound must be chronic (either dibetic or non diabetic) in orgin and larger than 1 cm square . Non diabetic wound will include venous and pressure ulcers.Patients presenting with 2 or more signs of infection (pain, erythema,
•warmth, swelling, discharge and malodour), but with reduced bacterial bioburden will be recruited for Diabetic and non diabetic wounds.
•3.Patient is willing to provide informed consent and is willing to
•participate in all procedures and follow up evaluations necessary to
•complete the study.
•4.The age of the wound between 3 months and one year, with documented
•failure of prior treatment to heal the wound will be selected.
•5.Patient has adequate circulation to the affected extremity, as
•demonstrated by one of the following in case of Diabetic and non
•diabetic ulcers, within the past 60 days: (For all patients)
•Doppler ABI result gretaer than or equal to 0.7 and less than or equal to 1.2 Doppler arterial waveforms, which are triphasic or biphasic at the
•ankle of affected leg.

•1.Patients presenting with a wound probing to bone (UT Grade IIIAD). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
•2.Patients whose index foot ulcers are greater than 25cm2 for diabetic wounds and greater than 50 cm2 for non diabetic wounds.
•3.Patients with a known history of poor compliance with medical treatments.
•4.Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
•5.Patients who are currently receiving radiation therapy or
•chemotherapy.
•6.Patients with known or suspected local skin malignancy to the index ulcer.
•7. Serum Creatinine more than 2 mg/dl and HbA1c more than 10%
•8. Non-revascularizable surgical sites.
•9. Patient who are pregnant or breastfeeding.
•10.Patient who are taking medications that are considered immune system modulator
•11.Allergy to the test or comparator products employed in the study.

发起方

CareNow Medical Pvt Ltd