Health Condition 1: null- Exudating wound and ulcers
Conditions
Interventions
Intervention1: MICROFOAM: Frequency of changing of dressing: Every 48 hours
Duration of dressing: 12 weeks
Sponsors
Viridis BioPharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patient must have an exudating ulcer. 2)Patient must be at least 18 years of age. 3)Wound debridement to be performed before enrollment whenever needed. 4)The study ulcer must be of minimum size 5 cm2. 5)For all patients with multiple chronic wounds, the Investigator will prospectively identify a designated "study ulcer" on Day O, i.e. on screening day. In patients with multiple ulcers, the largest ulcer that meets study requirements will be designated as the study ulcer. The study ulcer must be at least 4 cm away from all other ulcers at Study Day 0. 6)The patient, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form. 7)The patient must be available for evaluation on a weekly basis.
Exclusion criteria
Exclusion criteria: 1)History of substance abuse, within the previous year, which could, or in the judgment of the Investigator, would interfere with study compliance or protocol requirements. 2)Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study. 3)Pregnant females with positive UPT will be excluded from the study. 4) Patients with seropositive status will be excluded from the study. 5)Patient with a history of receiving any of the following within the last 30 days: systemic corticosteroids exceeding a total daily dose of 20mg, immunosuppressive agents, radiation therapy or chemotherapy. Anticipated use of the above during the study period will also exclude a patient from entry into the study. Topical and inhaled corticosteroids are not prohibited. 6)The patients with Glycosylated hemoglobin (HbA1C) more than 10.0% will be excluded from the study. 7)Patients with ABI lesser than 0.7 will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this pilot study is to evaluate Microfoam Barrier Foam dressings with regard to: 1) Effect on wound characteristics i.e. size, discharge, granulation. 2) Incidence of breakthrough in exudating wounds. 3) Microbiology of wound. 4) Time to wound closure by epithelization or readiness for skin graftingTimepoint: The primary objective of this pilot study is to evaluate Microfoam Barrier Foam dressings with regard to: 1) Effect on wound characteristics i.e. size, discharge, granulation. 2) Incidence of breakthrough in exudating wounds. 3) Microbiology of wound. 4) Time to wound closure by epithelization or readiness for skin grafting | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Yogesh Dound
Viridis BioPharma Pvt. Ltd.
Outcome results
None listed