Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg
Conditions
Interventions
Intervention1: Warm oxygen therapy: Warm oxygen therapy using KADAM for 90 minutes at 3 intervals of 30 minutes each given on alternate days for 6 weeks
Control Intervention1: NOT APPLICABLE: NOT APPL
Sponsors
Yostra Labs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with non-healing foot ulcer more than 6 weeks and less than 12 months 2. With any of the following etiology such as diabetic foot ulcers or ulcers with arterial or venous abnormality (or as per investigatorâ??s preference) a) Wagner-Meggitt Grade 2, 3. b) Above 18 years of age c) Of either gender
Exclusion criteria
Exclusion criteria: 1. Foot ulcers of other pathologies 2. Presence of invasive infection requiring intravenous antibiotics 3. Patients not willing to participate in the study 4. Any other medical condition that the investigator feels that the patient may not be eligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the effect of KADAM based oxygen therapy on percentage change in ulcer size at the end of 6 weeks To study the compliance and patient preference to KADAM based oxygen therapy To study the effect of KADAM based oxygen therapy on quality of life as measured using EQ-5D-5LTimepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the effect of KADAM based oxygen Therapy on glycaemic control Amputation, infection and hospitalisation rates over a 6 week follow-up periodTimepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr Robbie George
Mazumdar Shaw Medical Centre
Outcome results
None listed