Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg
Conditions
Interventions
Intervention1: Continuous Topical Oxygen Delivery Sleeve: Participants randomized to the intervention arm will receive continuous topical oxygen therapy using a limb-enclosing oxygen delivery sleeve c
Sponsors
Dwaarakesh MS
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years and above. Patients with hypoxic wounds of any duration. Swab negative acute surgical wounds. Wound size between 1 cm2 and 20 cm2 after appropriate debridement. Adequate limb perfusion deemed clinically acceptable by the investigator. Wounds suitable for topical therapy without immediate need for surgical closure. Ability and willingness to provide written informed consent. Willingness to comply with study procedures and attend scheduled follow-ups.
Exclusion criteria
Exclusion criteria: Critical limb ischemia or patients requiring urgent vascular intervention. Malignant wounds. Untreated osteomyelitis or severe soft tissue infection requiring immediate surgical management. Wounds with exposed major blood vessels, nerves, or organs where topical therapy may be unsafe. Severe uncontrolled systemic illness likely to impair wound healing e.g., advanced renal failure, severe hepatic disease, uncontrolled sepsis. Known hypersensitivity to materials used in study dressings. Pregnant or lactating women. Patients currently enrolled in another interventional clinical trial or who have participated in one within the previous 3 months. Any condition which, in the opinion of the investigator, makes the participant unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in wound area from baseline to 12 weeks measured using digital planimetry.Timepoint: Percentage reduction in wound area from baseline to 12 weeks measured using digital planimetry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to complete wound closure within the 12-week study period.Timepoint: Measured from date of randomization until complete epithelialization of the wound, assessed up to 12 weeks.;Feasibility of device use in routine ward settings with potential use in low resource centersTimepoint: Assessed throughout the 12-week study period. | — |
Countries
India
Contacts
Public ContactDwaarakesh M.S
Dept of General surgery, Saveetha medical college hospital and research centre
Outcome results
None listed