Health Condition 1: L984- Non-pressure chronic ulcer of skin, not elsewhere classified
Conditions
Interventions
Intervention1: Theruptor Novo 3 Dimensional Hydrocellular dressing pad: Theruptor NXT Non adherent
wound dressing pad is an active advanced wound care product. It consists of a 3-D Knitted Hydrocellul
Sponsors
Dr B Harish Darla
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged above 18 years with a mild to moderate exuding lower extremity wound, with size = 8 cm × 8 cm, with less than 50% of contraction in the past 4 weeks even after standard treatment 2. Patient willing to give written informed consent and adhere to study procedures
Exclusion criteria
Exclusion criteria: 1. Patients with wounds showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement 2. Patients with history of active Charcoat’s foot of the study foot within 6 months of screening 3. Patients undergoing treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, or radiotherapy 4. Pregnant or lactating mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of wound contraction as calculated by using the initial and final area every week for 4 weeks by using graded sterile centimetre ruler scaleTimepoint: Day 7, 14, 21, 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| A standardized UPPER and LOWER mnemonic for wound infection checklist incorporating a total of 10 signs and symptoms Timepoint: Day 1, 28 ;Subject satisfaction of wound healing using 5-point scaleTimepoint: Day 7, 14, 21, 28 ;To assess adverse eventsTimepoint: Day 1, 7, 14, 21, 28;To assess the percentage of granulation using wound photographsTimepoint: Day 1, 7, 14, 21, 28;Visual analogue scale (VAS) will be used to assess pain during dressing pad removal Timepoint: Day 7, 14, 21, 28 | — |
Countries
India
Contacts
Public ContactDr B Harish Darla
Darlas Health Care
Outcome results
None listed