To Determine Effectiveness ofTheruptor Sterile Barrier Wound Dressing In Chronic Infected wounds

Phase 2

• Conditions: Health Condition 1: L978- Non-pressure chronic ulcer of other part of lower legHealth Condition 2: L979- Non-pressure chronic ulcer of unspecified part of lower leg

• Registration Number: CTRI/2022/03/041044
• Lead Sponsor: CareNow Medical Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified