Health Condition 1: L899- Pressure ulcer of unspecified site Health Condition 2: I830- Varicose veins of lower extremities with ulcer Health Condition 3: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
None listed
Sponsors
OzoNiv Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants between 18 and 80 years (both years inclusive), all genders who consent to participate in the study and willing to comply with the protocol requirements. 2. Females of childbearing potential ? Negative urine pregnancy test and not breastfeeding and willing to avoid pregnancy during the study period by adopting acceptable method of contraception, such as hormonal methods (pills, patches, injections, implants, vaginal rings), barrier methods (condoms, diaphragms, cervical caps), intrauterine contraceptive devices (IUCDs), and sterilization. 3. Size of the ulcer ? Ranging from 0.5 cm2 to 25 cm2 4. Duration of ulcer - 3 weeks and more 5. Normal or clinically insignificant deviations of complete blood count, renal function tests and liver function tests 6. Haemoglobin level to be 10g/dl or more for females and 12g/dl or more for males and other genders 7. Ankle Brachial Pressure Index(ABPI) - 0.8 to 1.2. 8. Participants - with or without diabetes mellitus or hypertension or peripheral neuropathy 9. The comorbid conditions should be stable and controlled in view of the investigator 10. Ulcer must be of any one of the three types? diabetic ulcer or venous ulcer or pressure ulcer o In case of diabetic ulcer - Grade 1 or 2 of Wagner?s classification and the participants must be diabetic &HbA1c lesser than and equal to 12 percent o In case of venous ulcer - Doppler study showing venous insufficiency and HbA1c less than 9 percent in case of diabetics o In case of Pressure ulcer - Stage II and III as per the National Pressure Ulcer Advisory Panel (2007) classification and HbA1c less than 9 percent in case of diabetics
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to the study medication(s) 2. Ulcers having mixed etiologies 3. Ulcers with significant cellulitis and/or infection and/or gangrenous features in view of the investigator 4. Ulcers with osteomyelitis and/or exposed bone 5. Histopathology of ulcer showing malignancy 6. Participants with significant and unstable / uncontrolled / severe systemic disorders like cardiovascular, CNS, psychiatry, respiratory, gastrointestinal and renal diseases o Comorbid conditions related to the three types of ulcers included in the study such as diabetes mellitus, venous insufficiency and conditions leading to pressure sores are not excluded 7. Participants with tuberculosis, leprosy, lymphedema, deep venous thrombosis and other pathologies that can result in chronic and non ? healing ulcers 8. Participants with systemic sepsis 9. Concomitant medications other than what is required to treat diabetes and/or venous insufficiency and/or pressure ulcer and/or standard of care 10. Any other comorbid conditions that may affect the participants? safety in view of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the wound size, antimicrobial activity and changes in the histopathological examination. Timepoint: Baseline (0), weekly follow-up for 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Local and systemic adverse events. Timepoint: Weekly follow - up for 12 weeks | — |
Countries
India
Contacts
Public ContactArunkumar Radhakrishnan
Chettinad Hospital and Research Institute
Outcome results
None listed