Venous leg ulcers
Conditions
Interventions
The study will be conducted in the vascular clinics of the University Surgical Unit, Faculty of Medicine, Colombo.
Consenting participants meeting the inclusion/exclusion criteria will be randomized
the investigators will record the batch number and product investigation number at the time of the use. The details whether each product contain active drug or the placebo will be recorded by the phar
Sponsors
Department of Pharmacology
Department of Surgery
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients above 18 years with a single lower limb venous ulcer 2. Area of ulcer more than 4 cm2 and less than 25cm2 3. Duration of the ulcer less than 8 weeks 4. Duplex scan evidence of venous insufficiency demonstrated
Exclusion criteria
Exclusion criteria: 1. Patients who have the following comorbidities: a. Occlusive arterial disease – Ankle Brachial Pressure Index (ABPI) below 0.9 b. Uncontrolled diabetes mellitus with HbA1c > 8% or > 3 or more fasting blood glucose values in the last 6 months > 250mg/dl c. Chronic kidney disease Stage III and above d. Diagnosed chronic liver disease e. Heart failure NYHA class 3 or 4 f. Diagnosed Vasculitis g. Anemia with Hb less than 10g/dL 2. Recent (< 6 months) varicose vein surgery, laser ablation or sclerotherapy 3. Ulcers with infection/cellulitis/ osteomyelitis 4. Current smokers 5. Patients with history of allergy to phenytoin 6. Patients with epilepsy who are on oral phenytoin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of ulcers healed at the end of 12 weeks. Healing will be assessed based on wound surface area • Serial Digital Photographs will be taken by the same observer using a dedicated high resolution digital camera using a predetermined fixed distance. • The digital images will be analyzed by ‘ImageJ’ Image processing software and the wound surface area will be measured [At recruitment and weekly for 12 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of ulcers healed by 4 weeks, 8 weeks and 12 weeks in the two groups [At recruitment and weekly for 12 weeks] Average time taken to complete healing of wounds [At recruitment and weekly for 12 weeks] Time to reach skin grafting stage for ulcers larger than 12cm2 [At recruitment and weekly for 12 weeks ] Size of wound surface area in each week [At recruitment and weekly for 12 weeks ] Degree of pain relief experienced by the patient assessed weekly using a visual analog scale [At recruitment and weekly for 12 weeks ] Identification of adverse effects in both arms [At recruitment and weekly for 12 weeks ] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Priyadarshani Galappatthy
Professor
Outcome results
None listed