Health Condition 1: I832- Varicose veins of lower extremities with both ulcer and inflammation Health Condition 2: I830- Varicose veins of lower extremities with ulcer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Minimum of one venous leg ulcer Defined as any break in the skin that had either been present for longer than 4 weeks or occurred in a person with a history of venous leg ulceration. Ulcer is venous in appearance, moist, shallow, of an irregular shape and to lie wholly or partly within the gaiter region of the leg. 2. Duplex venous scan indicating venous insufficiency. 3. Ankle Brachial Index of more than or equal to 0.8. 4. In patients with bilateral venous ulcers, the worse affected limb will be studied. 5. In patients with multiple ulcers, the largest ulcer will be selected as the reference target ulcer.
Exclusion criteria
Exclusion criteria: 1. Patients with Arterial disease (ABI less than 0.8). 2. Mixed etiology ulcers (ABI 0.5 to 0.8). 3. Documented Congestive cardiac failure. 4. Venous Duplex Scan suggestive of deep vein thrombosis. 5. Past history of deep vein thrombosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to ulcer healing (weeks)Timepoint: 1 week and 6 weeks or upto complete healing of ulcer, whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in ulcer size (area) 2. Effect on ankle edema (circumference)Timepoint: 1 week and 6 weeks or upto complete healing of ulcer, whichever is earlier | — |
Countries
India
Contacts
Kasturba Medical College and Hospital Manipal